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）