心血管医疗器械中英文对照
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
870.20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 870.20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
870.30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）
