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《联邦规章典集》第21篇第870部[21CFR870],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 | 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 |