心血管医疗器械中英文对照

1、心血管医疗器械中英文对照    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 requirement for premarket approval870.9 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

2、 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 alarm870.1110 血压计算机 Blood pressure computer870.1120 血压袖带 Blood pressure cuff870.1130 非侵入式血压测量系统

3、 Noninvasive blood pressure measurement system870.1140 静脉血压计 Venous blood pressure manometer870.1200 诊断觲  Diagnostic intravascular catheter870.1210 连续式冲洗导管 Continuous flush catheter870.1220 电极记录导管或电极记录探针 Electrode recording catheter or electrode recording probe870.1230 光纤式血氧计导管 Fiberoptic oxime

4、ter catheter870.1240 导流导管 Flow-directed catheter870.1250 经皮导管 Percutaneous catheter870.1270 腔内心音导管系统 Intracavitary phonocatheter system870.1280 可操纵导管 Steerable catheter870.1290 可操纵导管控制系统 Steerable catheter control system870.1300 导管套管 Catheter cannula870.1310 经皮插入导管用的血管扩张器 Vessel dilator for percutan

5、eous catheterization870.1330 导管导线 Catheter guide wire870.1340 导管插入器 Catheter introducer870.1350 导管球囊修理工具盒 Catheter balloon 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 diagnostic compu

6、ter870.1435 预编程的单功能诊断用计算机 Single-function， preprogrammed diagnostic computer870.1450 光密度计 Densitometer870.1650 血管造影注器和注管 Angiographic injector and syringe870.1660 指示剂注器 Indicator injector870.1670 注器的注管制动器 Syringe actuator for an injector870.1750 体外可编程起搏器脉冲发生器 External programmable pacemaker pulse ge

7、nerator870.1800 抽缩式输液泵 Withdrawal-infusion pump870.1875 听诊器 Stethoscope870.1915 热稀释探头 Thermodilution probeC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 conditioner870.2060 传感器信号放大器和调节器 Transducer signal amplifier and conditioner870.2100 心血管血液流量

8、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 switching 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 Phonocardiograph870.2400 心电向量图仪 Vectorcardiograph870.2450 医用阴极线管显示器 Medical cathode-ray tube

10、 display870.2600 信号隔离系统 Signal isolation system870.2620 在线隔离监视器 Line isolation monitor870.2640 便携式漏电流警报器 Portable leakage current 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 Impedance phlebograph870.2770 阻抗式体积描记器 Impedance plethysmograph87

11、0.2780 水压式、气动式或光电式体积描记器 Hydraulic， pneumatic， or photoelectric plethysmographs870.2800 医用磁带记录器 Medical magnetic 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 transducer870.2850 血管外血压传感器 Extravascular blood pressure transducer870.2860 心音传感器 Heart sound transd

12、ucer870.2870 导管顶端压力传感器 Catheter tip pressure transducer870.2880 超声式传感器 Ultrasonic transducer870.2890 脉管闭塞传感器 Vessel occlusion transducer870.2900 患者传感器和电极电缆（包括连接器） Patient transducer and electrode cable （including connector）870.2910 频生理信号发送器和接收器 Radiofrequency physiological signal transmitter and rec

13、eiver870.2920 电话式心电图仪发送器和接收器 Telephone electrocardiograph transmitter 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 intravascular filter870.3450 血管移植假体 Vascula

14、r graft prosthesis870.3470 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 polytetrafluoroethylene870.3535 大动脉内球囊和控制系统 Intra-aortic balloon and control system870.3545 心室旁路（辅助）器械 Ventricular bypass （assist） device870.3600 体外起搏器脉冲发生器 Ext

15、ernal pacemaker pulse generator870.3610 植入式起搏器脉冲发生器 Implantable pacemaker pulse generator870.3620 起搏器导线接合器 Pacemaker lead adaptor870.3630 起搏器发生器功能分析仪 Pacemaker generator function analyzer870.3640 间接式起搏器发生器功能分析仪 Indirect pacemaker generator function analyzer870.3650 起搏器聚合体网袋 Pacemaker polymeric mesh

16、bag870.3670 起搏器充电器 Pacemaker charger870.3680 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 replacement material870.3720 起搏器电极功能检测器 Pacemaker electrode functio

17、n tester870.3730 起搏器维修工具 Pacemaker service tools870.3800 瓣环成形术环 Annuloplasty ring870.3850 颈动脉窦神经刺激器 Carotid sinus nerve stimulator870.3925 心脏瓣膜替代品 Replacement 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 D

18、evices）870.4075 心肌膜炎活组织检查器械 Endomyocardial biopsy device870.4200 心肺旁路附属设备 Cardiopulmonary bypass accessory equipment870.4205 心肺旁路气泡探测器 Cardiopulmonary bypass bubble detector870.4210 心肺旁路血管导管、套管或管路 Cardiopulmonary bypass vascular catheter， cannula， or tubing870.4220 心肺旁路心肺机控制台 Cardiopulmonary bypass

19、heart-lung machine console870.4230 心肺旁路消泡器 Cardiopulmonary bypass defoamer870.4240 心肺旁路热交换器 Cardiopulmonary bypass heat exchanger870.4250 心肺旁路温度控制器 Cardiopulmonary bypass temperature controller870.4260 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 Cardiopulmo

20、nary bypass cardiotomy suction line blood filter870.4280 心肺旁路前过滤器 Cardiopulmonary prebypass filter870.4290 心肺旁路接合器、旋塞阀、汇流管或配件 Cardiopulmonary bypass adaptor， stopcock， manifold， or fitting870.4300 心肺旁路气体控制装置 Cardiopulmonary bypass gas control unit870.4310 心肺旁路冠状动脉压力计 Cardiopulmonary bypass coronary

21、pressure gauge870.4320 心肺旁路脉动流发生器 Cardiopulmonary bypass pulsatile flow generator870.4330 心肺旁路即时血气监测仪 Cardiopulmonary bypass on-line blood gas monitor870.4340 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 Cardiopulmonary bypass oxygenator870.4360 非滚筒型心肺旁路血液泵 Nonroller-type cardiopulmonary bypass blood pump870.4370 滚筒型心肺旁路血液泵 Roller-type cardiopulmonary bypass blood pump870.4380 心肺旁路泵速度控制器 Cardiopulmonary bypass pump speed control870.4390 心肺旁路泵管路 Cardiopulmonary bypass pump tubing870.4400 心肺旁路血液储存器 Cardiopul