心血管医疗器械中英文对照

来源： 2018-02-28 16:49中

　A亚部--总则（General Provisions）

　　870.1 　　范围

　　870.3
　　Effective dates of requirement for premarket approval

　　870.9
　　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）

　　870.1100
　　Blood pressure alarm

　　870.1110
　　Blood pressure computer

　　870.1120
　　Blood pressure cuff

　　870.1130
　　Noninvasive blood pressure measurement system

　　870.1140
　　Venous blood pressure manometer

　　870.1200
　　Diagnostic intravascular catheter

　　870.1210
　　Continuous flush catheter

　　870.1220
　　Electrode recording catheter or electrode recording probe

　　870.1230
　　Fiberoptic oximeter catheter

　　870.1240
　　Flow-directed catheter

　　870.1250
　　Percutaneous catheter

　　870.1270
　　Intracavitary phonocatheter system

　　870.1280
　　Steerable catheter

　　870.1290
　　Steerable catheter control system

　　870.1300
　　Catheter cannula

　　870.1310
　　Vessel dilator for percutaneous catheterization

　　870.1330
　　Catheter guide wire

　　870.1340
　　Catheter introducer

　　870.1350
　　Catheter balloon repair kit

　　870.1360
　　Trace microsphere

　　870.1370
　　Catheter tip occluder

　　870.1380
　　Catheter stylet

　　870.1390
　　Trocar

　　870.1425
　　Programmable diagnostic computer

　　870.1435
　　Single-function, preprogrammed diagnostic computer

　　870.1450
　　Densitometer

　　870.1650
　　Angiographic injector and syringe

　　870.1660
　　Indicator injector

　　870.1670
　　Syringe actuator for an injector

　　870.1750
　　External programmable pacemaker pulse generator

　　870.1800
　　Withdrawal-infusion pump

　　870.1875
　　Stethoscope

　　870.1915
　　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

　　870.2060
　　Transducer signal amplifier and conditioner

　　870.2100
　　Cardiovascular blood flowmeter

　　870.2120
　　Extravascular blood flow probe

　　870.2300
　　Cardiac monitor （including cardiotachometer and rate alarm）

　　870.2310
　　Apex cardiograph （vibrocardiograph）

　　870.2320
　　Ballistocardiograph

　　870.2330
　　Echocardiograph

　　870.2340
　　Electrocardiograph

　　870.2350
　　Electrocardiograph lead switching adaptor

　　870.2360
　　Electrocardiograph electrode

　　870.2370
　　Electrocardiograph surface electrode tester

　　870.2390
　　Phonocardiograph

　　870.2400
　　Vectorcardiograph

　　870.2450
　　Medical cathode-ray tube display

　　870.2600
　　Signal isolation system

　　870.2620
　　Line isolation monitor

　　870.2640
　　Portable leakage current alarm

　　870.2675
　　Oscillometer

　　870.2700
　　Oximeter

　　870.2710
　　Ear oximeter

　　870.2750
　　Impedance phlebograph

　　870.2770
　　Impedance plethysmograph

　　870.2780
　　Hydraulic, pneumatic, or photoelectric plethysmographs

　　870.2800
　　Medical magnetic tape recorder

　　870.2810
　　Paper chart recorder

　　870.2840
　　Apex cardiographic transducer

　　870.2850
　　Extravascular blood pressure transducer

　　870.2860
　　Heart sound transducer

　　870.2870
　　Catheter tip pressure transducer

　　870.2880
　　Ultrasonic transducer

　　870.2890
　　Vessel occlusion transducer

　　870.2900
　　Patient transducer and electrode cable （including connector）

　　870.2910
　　Radiofrequency physiological signal transmitter and receiver

　　870.2920
　　Telephone electrocardiograph transmitter and receiver

　　D亚部--心血管修复器械（Cardiovascular Prosthetic Devices）

　　870.3250
　　Vascular clip

　　870.3260
　　Vena cava clip

　　870.3300
　　Arterial embolization device

　　870.3375
　　Cardiovascular intravascular filter

　　870.3450
　　Vascular graft prosthesis

　　870.3470
　　Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene

　　870.3535
　　Intra-aortic balloon and control system

　　870.3545