| 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 |
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 |
