有关上市前批准生效日期的要求  文件类型：PDF/Adobe Acrobat   文件大小：字节

Effective dates of requirement for premarket
approval
有关上市前批准生效日期的要求
Limitations of exemptions from section 510(k) of
the Federal Food, Drug, and Cosmetic Act (the
act)
联邦食品,药品和化妆品法
(FederalFood,Drug,andCosmeticAct,
FDCA)第510(k)节的豁免限制
Cardiovascular Diagnostic DevicesB亚部——心血管诊断器械
Arrhythmia detector and alarm (including ST-
segment measurement and alarm)
心律失常探测器和警报器(包括ST段测量和警报)
Blood pressure alarm血压警报器
Blood pressure computer血压计算机
Blood pressure cuff血压袖带
Noninvasive blood pressure measurement
system
非侵入式血压测量系统
Venous blood pressure manometer静脉血压计
Diagnostic intravascular catheter诊断用血管内导管
Continuous flush catheter连续式冲洗导管
Electrode recording catheter or electrode
recording probe
电极记录导管或电极记录探针
Fiberoptic oximeter catheter光纤式血氧计导管
Flow-directed catheter导流导管
Percutaneous catheter经皮导管
Intracavitary phonocatheter system腔内心音导管系统
Steerable catheter可操纵导管
Steerable catheter control system可操纵导管控制系统
Catheter cannula导管套管
Vessel dilator for percutaneous catheterization经皮插入导管用的血管扩张器
Catheter guide wire导管导线
Catheter introducer导管插入器
Catheter balloon repair kit导管球囊修理工具盒
Trace microsphere示踪微球体
Catheter tip occluder导管尖端封闭器
Catheter stylet导管探针
Trocar套管针
Programmable diagnostic computer可编程的诊断用计算机
Single-function, preprogrammed diagnostic
computer
预编程的单功能诊断用计算机
Densitometer光密度计
Angiographic injector and syringe血管造影注射器和注射管
Indicator injector指示剂注射器
Syringe actuator for an injector注射器的注射管制动器
External programmable pacemaker pulse
generator
体外可编程起搏器脉冲发生器
Withdrawal-infusion pump抽缩式输液泵
Stethoscope听诊器
Thermodilution probe热稀释探头
Cardiovascular Monitoring DevicesC亚部——心血管监测器械
Biopotential amplifier and signal conditioner生物电位放大器和信号调节器
Transducer signal amplifier and conditioner传感器信号放大器和调节器
Cardiovascular blood flowmeter心血管血液流量计
Extravascular blood flow probe血管外血流探头
Cardiac monitor (including cardiotachometer
and rate alarm)
心脏监测器(包括心率计和心率警报器)
Apex cardiograph (vibrocardiograph)尖端心动描记器(心振动图仪)
Ballistocardiograph心冲击描记器
Echocardiograph超声波心动图仪
Electrocardiograph心电图仪
Electrocardiograph lead switching adaptor心电图仪导线转换接合器
Electrocardiograph electrode心电图仪电极
Electrocardiograph surface electrode tester心电图仪表面电极检测器
Phonocardiograph心音图仪
Vectorcardiograph心电向量图仪
Medical cathode-ray tube display医用阴极射线管显示器
Signal isolation system信号隔离系统
Line isolation monitor在线隔离监视器
Portable leakage current alarm便携式漏电流警报器
Oscillometer动脉搏动描记器
Oximeter光电血氧计
Ear oximeter耳光电血氧计
Impedance phlebograph阻抗式静脉搏动描记器
Impedance plethysmograph阻抗式体积描记器
Hydraulic, pneumatic, or photoelectric
plethysmographs
水压式,气动式或光电式体积描记器
Medical magnetic tape recorder医用磁带记录器
Paper chart recorder纸质图表记录器
Apex cardiographic transducer尖端心动描记传感器
Extravascular blood pressure transducer血管外血压传感器
Heart sound transducer心音传感器
Catheter tip pressure transducer导管顶端压力传感器
Ultrasonic transducer超声式传感器
Vessel occlusion transducer脉管闭塞传感器
Patient transducer and electrode cable
(including connector)
患者传感器和电极电缆(包括连接器)
Radiofrequency physiological signal transmitter
and receiver
射频生理信号发送器和接收器
Telephone electrocardiograph transmitter and
receiver
电话式心电图仪发送器和接收器
Cardiovascular Prosthetic DevicesD亚部——心血管修复器械
Vascular clip血管夹
Vena cava clip腔静脉夹
Arterial embolization device动脉栓塞器械
Cardiovascular intravascular filter心血管内过滤器
Vascular graft prosthesis血管移植假体
Intracardiac patch or pledget made of
polypropylene, polyethylene terephthalate, or
polytetrafluoroethylene
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
Intra-aortic balloon and control system大动脉内球囊和控制系统
Ventricular bypass (assist) device心室旁路(辅助)器械
External pacemaker pulse generator体外起搏器脉冲发生器
Implantable pacemaker pulse generator植入式起搏器脉冲发生器
Pacemaker lead adaptor起搏器导线接合器
Pacemaker generator function analyzer起搏器发生器功能分析仪
Indirect pacemaker generator function analyzer间接式起搏器发生器功能分析仪
Pacemaker polymeric mesh bag起搏器聚合体网袋
Pacemaker charger起搏器充电器
Cardiovascular permanent or temporary
pacemaker electrode
心血管永久性或临时性起搏器电极
Pacemaker test magnet起搏器测试磁铁
Pacemaker programmers起搏器程序器
Pacemaker repair or replacement material起搏器修复或替换材料
Pacemaker electrode function tester起搏器电极功能检测器
Pacemaker service tools起搏器维修工具
Annuloplasty ring瓣环成形术环
Carotid sinus nerve stimulator颈动脉窦神经刺激器
Replacement heart valve心脏瓣膜替代品
Prosthetic heart valve holder心脏瓣膜假体支架
Prosthetic heart valve sizer心脏瓣膜假体筛选器
Cardiovascular Surgical DevicesE亚部——心血管手术器械
Endomyocardial biopsy device心肌膜炎活组织检查器械
Cardiopulmonary bypass accessory equipment心肺旁路附属设备
Cardiopulmonary bypass bubble detector心肺旁路气泡探测器
Cardiopulmonary bypass vascular catheter,
cannula, or tubing
心肺旁路血管导管,套管或管路
Cardiopulmonary bypass heart-lung machine
console
心肺旁路心肺机控制台
Cardiopulmonary bypass defoamer心肺旁路消泡器
Cardiopulmonary bypass heat exchanger心肺旁路热交换器
Cardiopulmonary bypass temperature controller心肺旁路温度控制器
Cardiopulmonary bypass arterial line blood filter心肺旁路动脉血过滤器
Cardiopulmonary bypass cardiotomy suction
line blood filter
心肺旁路心切开术抽吸管路血液过滤器
Cardiopulmonary prebypass filter心肺旁路前过滤器
Cardiopulmonary bypass adaptor, stopcock,
manifold, or fitting
心肺旁路接合器,旋塞阀,汇流管或配件
Cardiopulmonary bypass gas control unit心肺旁路气体控制装置
Cardiopulmonary bypass coronary pressure
gauge
心肺旁路冠状动脉压力计
Cardiopulmonary bypass pulsatile flow
generator
心肺旁路脉动流发生器
Cardiopulmonary bypass on-line blood gas
monitor
心肺旁路即时血气监测仪
Cardiopulmonary bypass level sensing monitor
and/or control
心肺旁路液面自动检测监视器和/或控制器
Cardiopulmonary bypass oxygenator心肺旁路氧合器
Nonroller-type cardiopulmonary bypass blood
pump
非滚筒型心肺旁路血液泵
Roller-type cardiopulmonary bypass blood pump滚筒型心肺旁路血液泵
Cardiopulmonary bypass pump speed control心肺旁路泵速度控制器
Cardiopulmonary bypass pump tubing心肺旁路泵管路
Cardiopulmonary bypass blood reservoir心肺旁路血液储存器
Cardiopulmonary bypass in-line blood gas
sensor
心肺旁路内嵌式血气传感器
Cardiopulmonary bypass cardiotomy return
sucker
心肺旁路心切开术返回吸管
Cardiopulmonary bypass intracardiac suction
control
心肺旁路心脏内抽吸控制器
Vascular clamp血管夹
Surgical vessel dilator外科手术血管扩张器
Cardiovascular surgical instruments心血管手术器具
Intraluminal artery stripper管腔内动脉剥离器
External vein stripper体外静脉剥离器
Cardiovascular Therapeutic DevicesF亚部——心血管治疗器械
Patient care suction apparatus患者照料吸引装置
Embolectomy catheter栓子切除导管
Septostomy catheter房隔造口导管
External cardiac compressor体外心脏挤压器
External counter-pulsating device体外反搏装置
DCDC-除颤器(包括除颤板)