1、医疗器械中英文对照心血管心血管器械(Cardiovascular Devices)联邦规章典集第21篇第870部21CFR870,节号中译文原英文A 亚部总则(General Provisions)870.1范围Scope870.3有关上市前批准生效日期的要求Effective dates of requireme nt for premarket approval870.9联邦食品、药品和化妆品法(Federal Limitations of exemptions from section 510(k) of theFood, Drug, and Cosmetic Act，FDCA)第 Fe

2、deral Food, Drug, and Cosmetic Act (the act)510( k)节的豁免限制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 measureme nt and alarm)870.1100血压警报器Blood pressure alarm870.1110血压计算机Blood pressure computer870.1120血压袖带Blood pre

3、ssure cuff870.1130非侵入式血压测量系统Nonin vasive blood pressure measureme nt system870.1140静脉血压计Venous blood pressure mano meter870.1200诊断用血管内导管Diag no stic in travascular catheter870.1210连续式冲洗导管Con ti nu ous flush catheter870.1220电极记录导管或电极记录探针Electrode record ing catheter or electrode record ing probe870.1

4、230光纤式血氧计导管Fiberoptic oximeter catheter870.1240导流导管Flow-directed catheter870.1250经皮导管Percuta neous catheter870.1270腔内心音导管系统In tracavitary phono catheter system870.1280可操纵导管Steerable catheter870.1290可操纵导管控制系统Steerable catheter con trol system870.1300导管套管Catheter cannula870.1310经皮插入导管用的血管扩张器Vessel dil

5、ator for percutaneous catheterization870.1330导管导线Catheter guide wire870.1340导管插入器Catheter in troducer870.1350导管球囊修理工具盒Catheter ballo on repair kit870.1360示踪微球体Trace microsphere870.1370导管尖端封闭器Catheter tip occluder870.1380导管探针Catheter stylet870.1390套管针Trocar870.1425可编程的诊断用计算机Programmable diag no stic

6、computer870.1435预编程的单功能诊断用计算机Sin gle-fu nction, preprogrammed diag no stic computer870.1450光密度计Den sitometer870.1650血管造影注射器和注射管An giographic injector and syri nge870.1660指示剂注射器In dicator injector870.1670注射器的注射管制动器Syringe actuator for an injector870.1750 r体外可编程起搏器脉冲发生器Exter nal programmable pacemaker

7、 pulse gen erator870.1800抽缩式输液泵Withdrawal-in fusi on pump870.1875听诊器Stethoscope870.1915热稀释探头Thermodiluti on probeC 亚部心血管监测器械(Cardiovascular Monitoring Devices )870.2050 r生物电位放大器和信号调节器Biopotential amplifier and signal conditioner870.2060传感器信号放大器和调节器Tran sducer sig nal amplifier and con diti oner870.2

8、100心血管血液流量计Cardiovascular blood flowmeter870.2120血管外血流探头Extravascular blood flow probe870.2300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Ballistocardiograph870.2330超声波心动图仪Echocardiograph870.2340

9、心电图仪Electrocardiograph870.2350心电图仪导线转换接合器Electrocardiograph lead switch ing adaptor870.2360心电图仪电极Electrocardiograph electrode870.2370心电图仪表面电极检测器Electrocardiograph surface electrode tester870.2390心音图仪Phono cardiograph870.2400心电向量图仪Vectorcardiograph870.2450医用阴极射线管显示器Medical cathode-ray tube display870

10、.2600信号隔离系统Signal isolati on system870.2620在线隔离监视器 Line isolati on mon itor870.2640便携式漏电流警报器Portable leakage curre nt alarm870.2675动脉搏动描记器Oscillometer870.2700光电血氧计Oximeter870.2710耳光电血氧计Ear oximeter870.2750阻抗式静脉搏动描记器Impeda nee phlebograph870.2770阻抗式体积描记器Impeda nee plethysmograph870.2780水压式、气动式或光电式体积描

11、记器Hydraulic, pn eumatic, or photoelectric plethysmographs870.2800医用磁带记录器Medical magn etic tape recorder870.2810纸质图表记录器Paper chart recorder870.2840尖端心动描记传感器Apex cardiographic tran sducer870.2850血管外血压传感器Extravascular blood pressure tran sducer870.2860心音传感器Heart sound tran sducer870.2870导管顶端压力传感器Cathet

12、er tip pressure tran sducer870.2880超声式传感器Ultras onic tran sducer870.2890脉管闭塞传感器Vessel occlusi on tran sducer870.2900患者传感器和电极电缆（包括连接器）Patient transducer and electrode cable (including conn ector)870.2910射频生理信号发送器和接收器Radiofrequency physiologicalsignal transmitter andreceiver870.2920电话式心电图仪发送器和接收器Telep

13、h one electrocardiograph tran smitter and receiverD 亚部心血管修复器械(Cardiovascular Prosthetic Devices )870.3250血管夹Vascular clip870.3260腔静脉夹Vena cava clip870.3300动脉栓塞器械Arterial embolization device870.3375心血管内过滤器Cardiovascular in travascular filter870.3450血管移植假体Vascular graft prosthesis870.3470聚丙烯、聚对苯二甲酸乙酯或

14、聚四氟乙 烯制成的心内补片或纱布Intracardiac patch or pledget made of polypropylene, polyethyle ne terephthalate, or polytetrafluoroethyle ne870.3535大动脉内球囊和控制系统In tra-aortic ballo on and con trol system870.3545心室旁路（辅助）器械Ven tricular bypass (assist) device870.3600体外起搏器脉冲发生器1Exter nal pacemaker pulse gen erator870.36

15、10植入式起搏器脉冲发生器Impla ntable pacemaker pulse gen erator870.3620起搏器导线接合器Pacemaker lead adaptor870.3630起搏器发生器功能分析仪Pacemaker gen erator fun cti on an alyzer870.3640间接式起搏器发生器功能分析仪In direct pacemaker gen erator fun ctio n an alyzer870.3650起搏器聚合体网袋 Pacemaker polymeric mesh bag870.3670起搏器充电器Pacemaker charger8

16、70.3680心血管永久性或临时性起搏器电极Cardiovascular permanent or temporary pacemaker electrode870.3690起搏器测试磁铁Pacemaker test magnet870.3700起搏器程序器Pacemaker programmers870.3710起搏器修复或替换材料Pacemaker repair or replaceme nt material870.3720起搏器电极功能检测器Pacemaker electrode function tester870.3730起搏器维修工具Pacemaker service tools

17、870.3800瓣环成形术环Annul oplasty ring870.3850颈动脉窦神经刺激器Carotid sinus nerve stimulator870.3925心脏瓣膜替代品Replaceme nt heart valve870.3935心脏瓣膜假体支架Prosthetic heart valve holder870.3945心脏瓣膜假体筛选器Prosthetic heart valve sizerE 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En domyocardial biopsy devic

18、e870.4200心肺旁路附属设备Cardiopul monary bypass accessory equipme nt870.4205心肺旁路气泡探测器Cardiopul monary bypass bubble detector870.4210心肺旁路血管导管、套管或管路Cardiopulmonary bypass vascular catheter, cannula, or tub ing870.4220心肺旁路心肺机控制台Cardiopul monary bypass heart-l ung mach ine con sole870.4230心肺旁路消泡器Cardiopul mona

19、ry bypass defoamer870.4240心肺旁路热交换器Cardiopul monary bypass heat excha nger870.4250r心肺旁路温度控制器Cardiopul monary bypass temperature con troller870.4260心肺旁路动脉血过滤器Cardiopulmonary bypass arterial line blood filter870.4270心肺旁路心切开术抽吸管路血液过滤器Cardiopulmonary bypass cardiotomy suction line blood filter870.4280心肺旁

20、路前过滤器Cardiopul monary prebypass filter870.4290心肺旁路接合器、旋塞阀、汇流管或配 件Cardiopul monary bypass adaptor, stopcock, mani fold, or fitting870.4300r心肺旁路气体控制装置Cardiopul monary bypass gas con trol unit870.4310心肺旁路冠状动脉压力计Cardiopul monary bypass coronary pressure gauge870.4320心肺旁路脉动流发生器Cardiopul monary bypass pul

21、satile flow gen erator870.4330心肺旁路即时血气监测仪Cardiopul monary bypass on-li ne blood gas mon itor870.4340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 control870.4350心肺旁路氧合器Cardiopul monary bypass oxyge nator870.4360非滚筒型心肺旁路血液泵Non roller-type cardiopul monary bypass blood pump870.4370滚筒型心肺旁路血液泵Roller-type cardiopul monary bypass blood pump870.4380心肺旁路泵速度控制器Cardiopul monary bypass pump speed con trol870.4390心肺旁路泵管路Cardiopul monary bypass pump tub ing870.4400心肺旁路血液储存器Cardiopu