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