A亚部——总则（General Provisions）

870.1
范围
Scope

870.3
有关上市前批准生效日期的要求
Effective dates of requirement for premarket approval

870.9
联邦食品、药品和化妆品法（Federal Food, Drug, and Cosmetic Act，FDCA）第510（k）节的豁免限制
Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act）

B亚部——心血管诊断器械（Cardiovascular Diagnostic Devices）

870.1025
心律失常探测器和警报器（包括ST段测量和警报）
Arrhythmia detector and alarm （including ST-segment measurement and alarm）

870.1100
血压警报器
Blood pressure alarm

870.1110
血压计算机
Blood pressure computer

870.1120
血压袖带
Blood pressure cuff

870.1130
非侵入式血压测量系统
Noninvasive blood pressure measurement system

870.1140
静脉血压计
Venous blood pressure manometer

870.1200
诊断用血管内导管
Diagnostic intravascular catheter

870.1210
连续式冲洗导管
Continuous flush catheter

870.1220
电极记录导管或电极记录探针
Electrode recording catheter or electrode recording probe

870.1230
光纤式血氧计导管
Fiberoptic oximeter catheter

870.1240
导流导管
Flow-directed catheter

870.1250
经皮导管
Percutaneous catheter

870.1270
腔内心音导管系统
Intracavitary phonocatheter system

870.1280
可操纵导管
Steerable catheter

870.1290
可操纵导管控制系统
Steerable catheter control system

870.1300
导管套管
Catheter cannula

870.1310
经皮插入导管用的血管扩张器
Vessel dilator for percutaneous catheterization

870.1330
导管导线
Catheter guide wire

870.1340
导管插入器
Catheter introducer

870.1350
导管球囊修理工具盒
Catheter balloon repair kit

870.1360
示踪微球体
Trace microsphere

870.1370
导管尖端封闭器
Catheter tip occluder

870.1380
导管探针
Catheter stylet

870.1390
套管针
Trocar

870.1425
可编程的诊断用计算机
Programmable diagnostic computer

870.1435
预编程的单功能诊断用计算机
Single-function, preprogrammed diagnostic computer

870.1450
光密度计
Densitometer

870.1650
血管造影注射器和注射管
Angiographic injector and syringe

870.1660
指示剂注射器
Indicator injector

870.1670
注射器的注射管制动器
Syringe actuator for an injector

870.1750
体外可编程起搏器脉冲发生器
External programmable pacemaker pulse generator

870.1800
抽缩式输液泵
Withdrawal-infusion pump

870.1875
听诊器
Stethoscope

870.1915
热稀释探头
Thermodilution probe

C亚部——心血管监测器械（Cardiovascular Monitoring Devices）

870.2050
生物电位放大器和信号调节器
Biopotential amplifier and signal conditioner

870.2060
传感器信号放大器和调节器
Transducer signal amplifier and conditioner

870.2100
心血管血液流量计
Cardiovascular blood flowmeter

870.2120
血管外血流探头
Extravascular blood flow probe

870.2300
心脏监测器（包括心率计和心率警报器）
Cardiac monitor （including cardiotachometer and rate alarm）

870.2310
尖端心动描记器（心振动图仪）
Apex cardiograph （vibrocardiograph）

870.2320
心冲击描记器
Ballistocardiograph

870.2330
超声波心动图仪
Echocardiograph

870.2340
心电图仪
Electrocardiograph

870.2350
心电图仪导线转换接合器
Electrocardiograph lead switching adaptor

870.2360
心电图仪电极
Electrocardiograph electrode

870.2370
心电图仪表面电极检测器
Electrocardiograph surface electrode tester

870.2390
心音图仪
Phonocardiograph

870.2400
心电向量图仪
Vectorcardiograph

870.2450
医用阴极射线管显示器
Medical cathode-ray tube display

870.2600
信号隔离系统
Signal isolation system

870.2620
在线隔离监视器
Line isolation monitor

870.2640
便携式漏电流警报器
Portable leakage current alarm

870.2675
动脉搏动描记器
Oscillometer

870.2700
光电血氧计
Oximeter

870.2710
耳光电血氧计
Ear oximeter

870.2750
阻抗式静脉搏动描记器
Impedance phlebograph

870.2770
阻抗式体积描记器
Impedance plethysmograph

870.2780
水压式、气动式或光电式体积描记器
Hydraulic, pneumatic, or photoelectric plethysmographs

870.2800
医用磁带记录器
Medical magnetic tape recorder

870.2810
纸质图表记录器
Paper chart recorder

870.2840
尖端心动描记传感器
Apex cardiographic transducer

870.2850
血管外血压传感器
Extravascular blood pressure transducer

870.2860
心音传感器
Heart sound transducer

870.2870
导管顶端压力传感器
Catheter tip pressure transducer

870.2880
超声式传感器
Ultrasonic transducer

870.2890
脉管闭塞传感器
Vessel occlusion transducer

870.2900
患者传感器和电极电缆（包括连接器）
Patient transducer and electrode cable （including connector）

870.2910
射频生理信号发送器和接收器
Radiofrequency physiological signal transmitter and receiver

870.2920
电话式心电图仪发送器和接收器
Telephone electrocardiograph transmitter and receiver

D亚部——心血管修复器械（Cardiovascular Prosthetic Devices）

870.3250
血管夹
Vascular clip

870.3260
腔静脉夹
Vena cava clip

870.3300
动脉栓塞器械
Arterial embolization device

870.3375
心血管内过滤器
Cardiovascular intravascular filter

870.3450
血管移植假体
Vascular graft prosthesis

870.3470
聚丙烯、聚对苯二甲酸乙酯或聚四氟乙烯制成的心内补片或纱布
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene

870.3535
大动脉内球囊和控制系统
Intra-aortic balloon and control system

870.3545
心室旁路（辅助）器械
Ventricular bypass （assist） device

870.3600
体外起搏器脉冲发生器
External pacemaker pulse generator

870.3610
植入式起搏器脉冲发生器
Implantable pacemaker pulse generator

870.3620
起搏器导线接合器
Pacemaker lead adaptor

870.3630
起搏器发生器功能分析仪
Pacemaker generator function analyzer

870.3640
间接式起搏器发生器功能分析仪
Indirect pacemaker generator function analyzer

870.3650
起搏器聚合体网袋
Pacemaker polymeric mesh bag

870.3670
起搏器充电器
Pacemaker charger

870.3680
心血管永久性或临时性起搏器电极
Cardiovascular permanent or temporary pacemaker electrode

870.3690
起搏器测试磁铁
Pacemaker test magnet

870.3700
起搏器程序器
Pacemaker programmers

870.3710
起搏器修复或替换材料
Pacemaker repair or replacement material

870.3720
起搏器电极功能检测器
Pacemaker electrode function tester

870.3730
起搏器维修工具
Pacemaker service tools

870.3800
瓣环成形术环
Annuloplasty ring

870.3850
颈动脉窦神经刺激器
Carotid sinus nerve stimulator

870.3925
心脏瓣膜替代品
Replacement heart valve

870.3935
心脏瓣膜假体支架
Prosthetic heart valve holder

870.3945
心脏瓣膜假体筛选器
Prosthetic heart valve sizer

E亚部——心血管手术器械（Cardiovascular Surgical Devices）

870.4075
心肌膜炎活组织检查器械
Endomyocardial biopsy device

870.4200
心肺旁路附属设备
Cardiopulmonary bypass accessory equipment

870.4205
心肺旁路气泡探测器
Cardiopulmonary bypass bubble detector

870.4210
心肺旁路血管导管、套管或管路
Cardiopulmonary bypass vascular catheter, cannula, or tubing

870.4220
心肺旁路心肺机控制台
Cardiopulmonary bypass heart-lung machine console

870.4230
心肺旁路消泡器
Cardiopulmonary bypass defoamer

870.4240
心肺旁路热交换器
Cardiopulmonary bypass heat exchanger

870.4250
心肺旁路温度控制器
Cardiopulmonary bypass temperature controller

870.4260
心肺旁路动脉血过滤器
Cardiopulmonary bypass arterial line blood filter

870.4270
心肺旁路心切开术抽吸管路血液过滤器
Cardiopulmonary bypass cardiotomy suction line blood filter

870.4280
心肺旁路前过滤器
Cardiopulmonary prebypass filter

870.4290
心肺旁路接合器、旋塞阀、汇流管或配件
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting

870.4300
心肺旁路气体控制装置
Cardiopulmonary bypass gas control unit

870.4310
心肺旁路冠状动脉压力计
Cardiopulmonary bypass coronary pressure gauge

870.4320
心肺旁路脉动流发生器
Cardiopulmonary bypass pulsatile flow generator

870.4330
心肺旁路即时血气监测仪
Cardiopulmonary bypass on-line blood gas monitor

870.4340
心肺旁路液面自动检测监视器和/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
非滚筒型心肺旁路血液泵
Nonroller-type cardiopulmonary bypass blood pump

870.4370
滚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
心肺旁路血液储存器
Cardiopulmonary bypass blood reservoir

870.4410
心肺旁路内嵌式血气传感器
Cardiopulmonary bypass in-line blood gas sensor

870.4420
心肺旁路心切开术返回吸管
Cardiopulmonary bypass cardiotomy return sucker

870.4430
心肺旁路心脏内抽吸控制器
Cardiopulmonary bypass intracardiac suction control

870.4450
血管夹
Vascular clamp

870.4475
外科手术血管扩张器
Surgical vessel dilator

870.4500
心血管手术器具
Cardiovascular surgical instruments

870.4875
管腔内动脉剥离器
Intraluminal artery stripper

870.4885
体外静脉剥离器
External vein stripper

F亚部 ——心血管治疗器械（Cardiovascular Therapeutic Devices）

870.5050
患者照料吸引装置
Patient care suction apparatus

870.5150
栓子切除导管
Embolectomy catheter

870.5175
房隔造口导管
Septostomy catheter

870.5200
体外心脏挤压器
External cardiac compressor

870.5225
体外反搏装置
External counter-pulsating device

870.5300
DC－除颤器（包括除颤板）
DC