中英对照——心血管器械

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中英对照——心血管器械

心血管器械 心血管器械 Cardiovascular Devices 节号 中译文 原英文 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

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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

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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

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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

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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

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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

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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

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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