A亞部——總則（General Provisions）
870.1
范圍
Scope
870.3
有關(guān)上市前批準(zhǔn)生效日期的要求
Effective dates of requirement for premarket approval
870.9
聯(lián)邦食品、藥品和化妝品法（Federal Food, Drug, and Cosmetic Act，F(xiàn)DCA）第510（k）節(jié)的豁免限制
Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act）
B亞部——心血管診斷器械（Cardiovascular Diagnostic Devices）
870.1025
心律失常探測器和警報器（包括ST段測量和警報）
Arrhythmia detector and alarm （including ST-segment measurement and alarm）
870.1100
血壓警報器
Blood pressure alarm
870.1110
血壓計算機(jī)
Blood pressure computer
870.1120
血壓袖帶
Blood pressure cuff
870.1130
非侵入式血壓測量系統(tǒng)
Noninvasive blood pressure measurement system
870.1140
靜脈血壓計
Venous blood pressure manometer
870.1200
診斷用血管內(nèi)導(dǎo)管
Diagnostic intravascular catheter
870.1210
連續(xù)式?jīng)_洗導(dǎo)管
Continuous flush catheter
870.1220
電極記錄導(dǎo)管或電極記錄探針
Electrode recording catheter or electrode recording probe
870.1230
光纖式血氧計導(dǎo)管
Fiberoptic oximeter catheter
870.1240
導(dǎo)流導(dǎo)管
Flow-directed catheter
870.1250
經(jīng)皮導(dǎo)管
Percutaneous catheter
870.1270
腔內(nèi)心音導(dǎo)管系統(tǒng)
Intracavitary phonocatheter system
870.1280
可操縱導(dǎo)管
Steerable catheter
870.1290
可操縱導(dǎo)管控制系統(tǒng)
Steerable catheter control system
870.1300
導(dǎo)管套管
Catheter cannula
870.1310
經(jīng)皮插入導(dǎo)管用的血管擴(kuò)張器
Vessel dilator for percutaneous catheterization
870.1330
導(dǎo)管導(dǎo)線
Catheter guide wire
870.1340
導(dǎo)管插入器
Catheter introducer
870.1350
導(dǎo)管球囊修理工具盒
Catheter balloon repair kit
870.1360
示蹤微球體
Trace microsphere
870.1370
導(dǎo)管尖端封閉器
Catheter tip occluder
870.1380
導(dǎo)管探針
Catheter stylet
870.1390
套管針
Trocar
870.1425
可編程的診斷用計算機(jī)
Programmable diagnostic computer
870.1435
預(yù)編程的單功能診斷用計算機(jī)
Single-function, preprogrammed diagnostic computer
870.1450
光密度計
Densitometer
870.1650
血管造影注射器和注射管
Angiographic injector and syringe
870.1660
指示劑注射器
Indicator injector
870.1670
注射器的注射管制動器
Syringe actuator for an injector
870.1750
體外可編程起搏器脈沖發(fā)生器
External programmable pacemaker pulse generator
870.1800
抽縮式輸液泵
Withdrawal-infusion pump
870.1875
聽診器
Stethoscope
870.1915
熱稀釋探頭
Thermodilution probe
C亞部——心血管監(jiān)測器械（Cardiovascular Monitoring Devices）
870.2050
生物電位放大器和信號調(diào)節(jié)器
Biopotential amplifier and signal conditioner
870.2060
傳感器信號放大器和調(diào)節(jié)器
Transducer signal amplifier and conditioner
870.2100
心血管血液流量計
Cardiovascular blood flowmeter
870.2120
血管外血流探頭
Extravascular blood flow probe
870.2300
心臟監(jiān)測器（包括心率計和心率警報器）
Cardiac monitor （including cardiotachometer and rate alarm）
870.2310
尖端心動描記器（心振動圖儀）
Apex cardiograph （vibrocardiograph）
870.2320
心沖擊描記器
Ballistocardiograph
870.2330
超聲波心動圖儀
Echocardiograph
870.2340
心電圖儀
Electrocardiograph
870.2350
心電圖儀導(dǎo)線轉(zhuǎn)換接合器
Electrocardiograph lead switching adaptor
870.2360
心電圖儀電極
Electrocardiograph electrode
870.2370
心電圖儀表面電極檢測器
Electrocardiograph surface electrode tester
870.2390
心音圖儀
Phonocardiograph
870.2400
心電向量圖儀
Vectorcardiograph
870.2450
醫(yī)用陰極射線管顯示器
Medical cathode-ray tube display
870.2600
信號隔離系統(tǒng)
Signal isolation system
870.2620
在線隔離監(jiān)視器
Line isolation monitor
870.2640
便攜式漏電流警報器
Portable leakage current alarm
870.2675
動脈搏動描記器
Oscillometer
870.2700
光電血氧計
Oximeter
870.2710
耳光電血氧計
Ear oximeter
870.2750
阻抗式靜脈搏動描記器
Impedance phlebograph
870.2770
阻抗式體積描記器
Impedance plethysmograph
870.2780
水壓式、氣動式或光電式體積描記器
Hydraulic, pneumatic, or photoelectric plethysmographs
870.2800
醫(yī)用磁帶記錄器
Medical magnetic tape recorder
870.2810
紙質(zhì)圖表記錄器
Paper chart recorder
870.2840
尖端心動描記傳感器
Apex cardiographic transducer
870.2850
血管外血壓傳感器
Extravascular blood pressure transducer
870.2860
心音傳感器
Heart sound transducer
870.2870
導(dǎo)管頂端壓力傳感器
Catheter tip pressure transducer
870.2880
超聲式傳感器
Ultrasonic transducer
870.2890
脈管閉塞傳感器
Vessel occlusion transducer
870.2900
患者傳感器和電極電纜（包括連接器）
Patient transducer and electrode cable （including connector）
870.2910
射頻生理信號發(fā)送器和接收器
Radiofrequency physiological signal transmitter and receiver
870.2920
電話式心電圖儀發(fā)送器和接收器
Telephone electrocardiograph transmitter and receiver
D亞部——心血管修復(fù)器械（Cardiovascular Prosthetic Devices）
870.3250
血管夾
Vascular clip
870.3260
腔靜脈夾
Vena cava clip
870.3300
動脈栓塞器械
Arterial embolization device
870.3375
心血管內(nèi)過濾器
Cardiovascular intravascular filter
870.3450
血管移植假體
Vascular graft prosthesis
870.3470
聚丙烯、聚對苯二甲酸乙酯或聚四氟乙烯制成的心內(nèi)補(bǔ)片或紗布
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
870.3535
大動脈內(nèi)球囊和控制系統(tǒng)
Intra-aortic balloon and control system
870.3545
心室旁路（輔助）器械
Ventricular bypass （assist） device
870.3600
體外起搏器脈沖發(fā)生器
External pacemaker pulse generator
870.3610
植入式起搏器脈沖發(fā)生器
Implantable pacemaker pulse generator
870.3620
起搏器導(dǎo)線接合器
Pacemaker lead adaptor
870.3630
起搏器發(fā)生器功能分析儀
Pacemaker generator function analyzer
870.3640
間接式起搏器發(fā)生器功能分析儀
Indirect pacemaker generator function analyzer
870.3650
起搏器聚合體網(wǎng)袋
Pacemaker polymeric mesh bag
870.3670
起搏器充電器
Pacemaker charger
870.3680
心血管永久性或臨時性起搏器電極
Cardiovascular permanent or temporary pacemaker electrode
870.3690
起搏器測試磁鐵
Pacemaker test magnet
870.3700
起搏器程序器
Pacemaker programmers
870.3710
起搏器修復(fù)或替換材料
Pacemaker repair or replacement material
870.3720
起搏器電極功能檢測器
Pacemaker electrode function tester
870.3730
起搏器維修工具
Pacemaker service tools
870.3800
瓣環(huán)成形術(shù)環(huán)
Annuloplasty ring
870.3850
頸動脈竇神經(jīng)刺激器
Carotid sinus nerve stimulator
870.3925
心臟瓣膜替代品
Replacement heart valve
870.3935
心臟瓣膜假體支架
Prosthetic heart valve holder
870.3945
心臟瓣膜假體篩選器
Prosthetic heart valve sizer
E亞部——心血管手術(shù)器械（Cardiovascular Surgical Devices）
870.4075
心肌膜炎活組織檢查器械
Endomyocardial biopsy device
870.4200
心肺旁路附屬設(shè)備
Cardiopulmonary bypass accessory equipment
870.4205
心肺旁路氣泡探測器
Cardiopulmonary bypass bubble detector
870.4210
心肺旁路血管導(dǎo)管、套管或管路
Cardiopulmonary bypass vascular catheter, cannula, or tubing
870.4220
心肺旁路心肺機(jī)控制臺
Cardiopulmonary bypass heart-lung machine console
870.4230
心肺旁路消泡器
Cardiopulmonary bypass defoamer
870.4240
心肺旁路熱交換器
Cardiopulmonary bypass heat exchanger
870.4250
心肺旁路溫度控制器
Cardiopulmonary bypass temperature controller
870.4260
心肺旁路動脈血過濾器
Cardiopulmonary bypass arterial line blood filter
870.4270
心肺旁路心切開術(shù)抽吸管路血液過濾器
Cardiopulmonary bypass cardiotomy suction line blood filter
870.4280
心肺旁路前過濾器
Cardiopulmonary prebypass filter
870.4290
心肺旁路接合器、旋塞閥、匯流管或配件
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting
870.4300
心肺旁路氣體控制裝置
Cardiopulmonary bypass gas control unit
870.4310
心肺旁路冠狀動脈壓力計
Cardiopulmonary bypass coronary pressure gauge
870.4320
心肺旁路脈動流發(fā)生器
Cardiopulmonary bypass pulsatile flow generator
870.4330
心肺旁路即時血?dú)獗O(jiān)測儀
Cardiopulmonary bypass on-line blood gas monitor
870.4340
心肺旁路液面自動檢測監(jiān)視器和/或控制器
Cardiopulmonary bypass level sensing monitor and/or control
870.4350
心肺旁路氧合器
Cardiopulmonary bypass oxygenator
870.4360
非滾筒型心肺旁路血液泵
Nonroller-type cardiopulmonary bypass blood pump
870.4370
滾筒型心肺旁路血液泵
Roller-type cardiopulmonary bypass blood pump
870.4380
心肺旁路泵速度控制器
Cardiopulmonary bypass pump speed control
870.4390
心肺旁路泵管路
Cardiopulmonary bypass pump tubing
870.4400
心肺旁路血液儲存器
Cardiopulmonary bypass blood reservoir
870.4410
心肺旁路內(nèi)嵌式血?dú)鈧鞲衅?BR> Cardiopulmonary bypass in-line blood gas sensor
870.4420
心肺旁路心切開術(shù)返回吸管
Cardiopulmonary bypass cardiotomy return sucker
870.4430
心肺旁路心臟內(nèi)抽吸控制器
Cardiopulmonary bypass intracardiac suction control
870.4450
血管夾
Vascular clamp
870.4475
外科手術(shù)血管擴(kuò)張器
Surgical vessel dilator
870.4500
心血管手術(shù)器具
Cardiovascular surgical instruments
870.4875
管腔內(nèi)動脈剝離器
Intraluminal artery stripper
870.4885
體外靜脈剝離器
External vein stripper
F亞部 ——心血管治療器械（Cardiovascular Therapeutic Devices）
870.5050
患者照料吸引裝置
Patient care suction apparatus
870.5150
栓子切除導(dǎo)管
Embolectomy catheter
870.5175
房隔造口導(dǎo)管
Septostomy catheter
870.5200
體外心臟擠壓器
External cardiac compressor
870.5225
體外反搏裝置
External counter-pulsating device
870.5300
DC－除顫器（包括除顫板）
DC
870.1
范圍
Scope
870.3
有關(guān)上市前批準(zhǔn)生效日期的要求
Effective dates of requirement for premarket approval
870.9
聯(lián)邦食品、藥品和化妝品法（Federal Food, Drug, and Cosmetic Act，F(xiàn)DCA）第510（k）節(jié)的豁免限制
Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act）
B亞部——心血管診斷器械（Cardiovascular Diagnostic Devices）
870.1025
心律失常探測器和警報器（包括ST段測量和警報）
Arrhythmia detector and alarm （including ST-segment measurement and alarm）
870.1100
血壓警報器
Blood pressure alarm
870.1110
血壓計算機(jī)
Blood pressure computer
870.1120
血壓袖帶
Blood pressure cuff
870.1130
非侵入式血壓測量系統(tǒng)
Noninvasive blood pressure measurement system
870.1140
靜脈血壓計
Venous blood pressure manometer
870.1200
診斷用血管內(nèi)導(dǎo)管
Diagnostic intravascular catheter
870.1210
連續(xù)式?jīng)_洗導(dǎo)管
Continuous flush catheter
870.1220
電極記錄導(dǎo)管或電極記錄探針
Electrode recording catheter or electrode recording probe
870.1230
光纖式血氧計導(dǎo)管
Fiberoptic oximeter catheter
870.1240
導(dǎo)流導(dǎo)管
Flow-directed catheter
870.1250
經(jīng)皮導(dǎo)管
Percutaneous catheter
870.1270
腔內(nèi)心音導(dǎo)管系統(tǒng)
Intracavitary phonocatheter system
870.1280
可操縱導(dǎo)管
Steerable catheter
870.1290
可操縱導(dǎo)管控制系統(tǒng)
Steerable catheter control system
870.1300
導(dǎo)管套管
Catheter cannula
870.1310
經(jīng)皮插入導(dǎo)管用的血管擴(kuò)張器
Vessel dilator for percutaneous catheterization
870.1330
導(dǎo)管導(dǎo)線
Catheter guide wire
870.1340
導(dǎo)管插入器
Catheter introducer
870.1350
導(dǎo)管球囊修理工具盒
Catheter balloon repair kit
870.1360
示蹤微球體
Trace microsphere
870.1370
導(dǎo)管尖端封閉器
Catheter tip occluder
870.1380
導(dǎo)管探針
Catheter stylet
870.1390
套管針
Trocar
870.1425
可編程的診斷用計算機(jī)
Programmable diagnostic computer
870.1435
預(yù)編程的單功能診斷用計算機(jī)
Single-function, preprogrammed diagnostic computer
870.1450
光密度計
Densitometer
870.1650
血管造影注射器和注射管
Angiographic injector and syringe
870.1660
指示劑注射器
Indicator injector
870.1670
注射器的注射管制動器
Syringe actuator for an injector
870.1750
體外可編程起搏器脈沖發(fā)生器
External programmable pacemaker pulse generator
870.1800
抽縮式輸液泵
Withdrawal-infusion pump
870.1875
聽診器
Stethoscope
870.1915
熱稀釋探頭
Thermodilution probe
C亞部——心血管監(jiān)測器械（Cardiovascular Monitoring Devices）
870.2050
生物電位放大器和信號調(diào)節(jié)器
Biopotential amplifier and signal conditioner
870.2060
傳感器信號放大器和調(diào)節(jié)器
Transducer signal amplifier and conditioner
870.2100
心血管血液流量計
Cardiovascular blood flowmeter
870.2120
血管外血流探頭
Extravascular blood flow probe
870.2300
心臟監(jiān)測器（包括心率計和心率警報器）
Cardiac monitor （including cardiotachometer and rate alarm）
870.2310
尖端心動描記器（心振動圖儀）
Apex cardiograph （vibrocardiograph）
870.2320
心沖擊描記器
Ballistocardiograph
870.2330
超聲波心動圖儀
Echocardiograph
870.2340
心電圖儀
Electrocardiograph
870.2350
心電圖儀導(dǎo)線轉(zhuǎn)換接合器
Electrocardiograph lead switching adaptor
870.2360
心電圖儀電極
Electrocardiograph electrode
870.2370
心電圖儀表面電極檢測器
Electrocardiograph surface electrode tester
870.2390
心音圖儀
Phonocardiograph
870.2400
心電向量圖儀
Vectorcardiograph
870.2450
醫(yī)用陰極射線管顯示器
Medical cathode-ray tube display
870.2600
信號隔離系統(tǒng)
Signal isolation system
870.2620
在線隔離監(jiān)視器
Line isolation monitor
870.2640
便攜式漏電流警報器
Portable leakage current alarm
870.2675
動脈搏動描記器
Oscillometer
870.2700
光電血氧計
Oximeter
870.2710
耳光電血氧計
Ear oximeter
870.2750
阻抗式靜脈搏動描記器
Impedance phlebograph
870.2770
阻抗式體積描記器
Impedance plethysmograph
870.2780
水壓式、氣動式或光電式體積描記器
Hydraulic, pneumatic, or photoelectric plethysmographs
870.2800
醫(yī)用磁帶記錄器
Medical magnetic tape recorder
870.2810
紙質(zhì)圖表記錄器
Paper chart recorder
870.2840
尖端心動描記傳感器
Apex cardiographic transducer
870.2850
血管外血壓傳感器
Extravascular blood pressure transducer
870.2860
心音傳感器
Heart sound transducer
870.2870
導(dǎo)管頂端壓力傳感器
Catheter tip pressure transducer
870.2880
超聲式傳感器
Ultrasonic transducer
870.2890
脈管閉塞傳感器
Vessel occlusion transducer
870.2900
患者傳感器和電極電纜（包括連接器）
Patient transducer and electrode cable （including connector）
870.2910
射頻生理信號發(fā)送器和接收器
Radiofrequency physiological signal transmitter and receiver
870.2920
電話式心電圖儀發(fā)送器和接收器
Telephone electrocardiograph transmitter and receiver
D亞部——心血管修復(fù)器械（Cardiovascular Prosthetic Devices）
870.3250
血管夾
Vascular clip
870.3260
腔靜脈夾
Vena cava clip
870.3300
動脈栓塞器械
Arterial embolization device
870.3375
心血管內(nèi)過濾器
Cardiovascular intravascular filter
870.3450
血管移植假體
Vascular graft prosthesis
870.3470
聚丙烯、聚對苯二甲酸乙酯或聚四氟乙烯制成的心內(nèi)補(bǔ)片或紗布
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
870.3535
大動脈內(nèi)球囊和控制系統(tǒng)
Intra-aortic balloon and control system
870.3545
心室旁路（輔助）器械
Ventricular bypass （assist） device
870.3600
體外起搏器脈沖發(fā)生器
External pacemaker pulse generator
870.3610
植入式起搏器脈沖發(fā)生器
Implantable pacemaker pulse generator
870.3620
起搏器導(dǎo)線接合器
Pacemaker lead adaptor
870.3630
起搏器發(fā)生器功能分析儀
Pacemaker generator function analyzer
870.3640
間接式起搏器發(fā)生器功能分析儀
Indirect pacemaker generator function analyzer
870.3650
起搏器聚合體網(wǎng)袋
Pacemaker polymeric mesh bag
870.3670
起搏器充電器
Pacemaker charger
870.3680
心血管永久性或臨時性起搏器電極
Cardiovascular permanent or temporary pacemaker electrode
870.3690
起搏器測試磁鐵
Pacemaker test magnet
870.3700
起搏器程序器
Pacemaker programmers
870.3710
起搏器修復(fù)或替換材料
Pacemaker repair or replacement material
870.3720
起搏器電極功能檢測器
Pacemaker electrode function tester
870.3730
起搏器維修工具
Pacemaker service tools
870.3800
瓣環(huán)成形術(shù)環(huán)
Annuloplasty ring
870.3850
頸動脈竇神經(jīng)刺激器
Carotid sinus nerve stimulator
870.3925
心臟瓣膜替代品
Replacement heart valve
870.3935
心臟瓣膜假體支架
Prosthetic heart valve holder
870.3945
心臟瓣膜假體篩選器
Prosthetic heart valve sizer
E亞部——心血管手術(shù)器械（Cardiovascular Surgical Devices）
870.4075
心肌膜炎活組織檢查器械
Endomyocardial biopsy device
870.4200
心肺旁路附屬設(shè)備
Cardiopulmonary bypass accessory equipment
870.4205
心肺旁路氣泡探測器
Cardiopulmonary bypass bubble detector
870.4210
心肺旁路血管導(dǎo)管、套管或管路
Cardiopulmonary bypass vascular catheter, cannula, or tubing
870.4220
心肺旁路心肺機(jī)控制臺
Cardiopulmonary bypass heart-lung machine console
870.4230
心肺旁路消泡器
Cardiopulmonary bypass defoamer
870.4240
心肺旁路熱交換器
Cardiopulmonary bypass heat exchanger
870.4250
心肺旁路溫度控制器
Cardiopulmonary bypass temperature controller
870.4260
心肺旁路動脈血過濾器
Cardiopulmonary bypass arterial line blood filter
870.4270
心肺旁路心切開術(shù)抽吸管路血液過濾器
Cardiopulmonary bypass cardiotomy suction line blood filter
870.4280
心肺旁路前過濾器
Cardiopulmonary prebypass filter
870.4290
心肺旁路接合器、旋塞閥、匯流管或配件
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting
870.4300
心肺旁路氣體控制裝置
Cardiopulmonary bypass gas control unit
870.4310
心肺旁路冠狀動脈壓力計
Cardiopulmonary bypass coronary pressure gauge
870.4320
心肺旁路脈動流發(fā)生器
Cardiopulmonary bypass pulsatile flow generator
870.4330
心肺旁路即時血?dú)獗O(jiān)測儀
Cardiopulmonary bypass on-line blood gas monitor
870.4340
心肺旁路液面自動檢測監(jiān)視器和/或控制器
Cardiopulmonary bypass level sensing monitor and/or control
870.4350
心肺旁路氧合器
Cardiopulmonary bypass oxygenator
870.4360
非滾筒型心肺旁路血液泵
Nonroller-type cardiopulmonary bypass blood pump
870.4370
滾筒型心肺旁路血液泵
Roller-type cardiopulmonary bypass blood pump
870.4380
心肺旁路泵速度控制器
Cardiopulmonary bypass pump speed control
870.4390
心肺旁路泵管路
Cardiopulmonary bypass pump tubing
870.4400
心肺旁路血液儲存器
Cardiopulmonary bypass blood reservoir
870.4410
心肺旁路內(nèi)嵌式血?dú)鈧鞲衅?BR> Cardiopulmonary bypass in-line blood gas sensor
870.4420
心肺旁路心切開術(shù)返回吸管
Cardiopulmonary bypass cardiotomy return sucker
870.4430
心肺旁路心臟內(nèi)抽吸控制器
Cardiopulmonary bypass intracardiac suction control
870.4450
血管夾
Vascular clamp
870.4475
外科手術(shù)血管擴(kuò)張器
Surgical vessel dilator
870.4500
心血管手術(shù)器具
Cardiovascular surgical instruments
870.4875
管腔內(nèi)動脈剝離器
Intraluminal artery stripper
870.4885
體外靜脈剝離器
External vein stripper
F亞部 ——心血管治療器械（Cardiovascular Therapeutic Devices）
870.5050
患者照料吸引裝置
Patient care suction apparatus
870.5150
栓子切除導(dǎo)管
Embolectomy catheter
870.5175
房隔造口導(dǎo)管
Septostomy catheter
870.5200
體外心臟擠壓器
External cardiac compressor
870.5225
體外反搏裝置
External counter-pulsating device
870.5300
DC－除顫器（包括除顫板）
DC