1、豆丁|英語，用請下載醫(yī)療器械名稱中英文對照（心血管相關(guān)）心血管器械（cardiovascular devices）節(jié)號中譯文原英文a亞部總則（general provisions）870.1范圍scope870.3有關(guān)上市前批準(zhǔn)生效日期的要求effective dates of requirement for premarket approval870.9 聯(lián)邦食品、藥品和化妝品法（federal food, drug, and cosmetic act，fdca）第510（k）節(jié)的豁免限制limitations of exemptions from section 510（k） of the

2、 federal food, drug, and cosmetic act （the act）b亞部心血管診斷器械（cardiovascular diagnostic devices）870.1025心律失常探測器和警報器（包括st段測量和警報）arrhythmia detector and alarm （including st-segment measurement and alarm）870.1100血壓警報器 blood pressure alarm870.1110血壓計算機blood pressure computer870.1120血壓袖帶blood pressure cuff87

3、0.1130非侵入式血壓測量系統(tǒng)noninvasive blood pressure measurement system870.1140靜脈血壓計venous blood pressure manometer870.1200診斷用血管內(nèi)導(dǎo)管diagnostic intravascular catheter870.1210連續(xù)式?jīng)_洗導(dǎo)管continuous flush catheter870.1220電極記錄導(dǎo)管或電極記錄探針electrode recording catheter or electrode recording probe870.1230光纖式血氧計導(dǎo)管fiberoptic o

4、ximeter catheter870.1240導(dǎo)流導(dǎo)管flow-directed catheter870.1250經(jīng)皮導(dǎo)管percutaneous catheter870.1270腔內(nèi)心音導(dǎo)管系統(tǒng)intracavitary phonocatheter system870.1280可操縱導(dǎo)管steerable catheter870.1290可操縱導(dǎo)管控制系統(tǒng)steerable catheter control system870.1300導(dǎo)管套管catheter cannula870.1310經(jīng)皮插入導(dǎo)管用的血管擴張器vessel dilator for percutaneous cathe

5、terization870.1330導(dǎo)管導(dǎo)線catheter guide wire870.1340導(dǎo)管插入器catheter introducer870.1350導(dǎo)管球囊修理工具盒catheter balloon repair kit870.1360示蹤微球體trace microsphere870.1370導(dǎo)管尖端封閉器catheter tip occluder870.1380導(dǎo)管探針catheter stylet870.1390套管針trocar870.1425可編程的診斷用計算機programmable diagnostic computer870.1435預(yù)編程的單功能診斷用計算機si

6、ngle-function, preprogrammed diagnostic computer870.1450光密度計densitometer870.1650血管造影注射器和注射管angiographic injector and syringe870.1660指示劑注射器indicator injector870.1670注射器的注射管制動器syringe actuator for an injector870.1750體外可編程起搏器脈沖發(fā)生器external programmable pacemaker pulse generator870.1800抽縮式輸液泵withdrawal-i

7、nfusion pump870.1875聽診器stethoscope870.1915熱稀釋探頭thermodilution probec亞部心血管監(jiān)測器械（cardiovascular monitoring devices）870.2050生物電位放大器和信號調(diào)節(jié)器biopotential amplifier and signal conditioner870.2060傳感器信號放大器和調(diào)節(jié)器transducer signal amplifier and conditioner870.2100 心血管血液流量計cardiovascular blood flowmeter870.2120 血管外

8、血流探頭extravascular blood flow probe870.2300心臟監(jiān)測器（包括心率計和心率警報器）cardiac monitor （including cardiotachometer and rate alarm）870.2310尖端心動描記器（心振動圖儀）apex cardiograph （vibrocardiograph）870.2320心沖擊描記器ballistocardiograph870.2330 超聲波心動圖儀echocardiograph870.2340心電圖儀electrocardiograph870.2350 心電圖儀導(dǎo)線轉(zhuǎn)換接合器electrocar

9、diograph lead switching adaptor870.2360心電圖儀電極electrocardiograph electrode870.2370 心電圖儀表面電極檢測器electrocardiograph surface electrode tester870.2390心音圖儀phonocardiograph870.2400心電向量圖儀vectorcardiograph870.2450醫(yī)用陰極射線管顯示器medical cathode-ray tube display870.2600信號隔離系統(tǒng)signal isolation system870.2620在線隔離監(jiān)視器lin

10、e isolation monitor870.2640便攜式漏電流警報器portable leakage current alarm870.2675動脈搏動描記器oscillometer870.2700光電血氧計oximeter870.2710耳光電血氧計ear oximeter870.2750阻抗式靜脈搏動描記器impedance phlebograph870.2770阻抗式體積描記器impedance plethysmograph870.2780水壓式、氣動式或光電式體積描記器hydraulic, pneumatic, or photoelectric plethysmographs870

11、.2800醫(yī)用磁帶記錄器medical magnetic tape recorder870.2810紙質(zhì)圖表記錄器paper chart recorder870.2840尖端心動描記傳感器apex cardiographic transducer870.2850血管外血壓傳感器extravascular blood pressure transducer870.2860心音傳感器heart sound transducer870.2870導(dǎo)管頂端壓力傳感器catheter tip pressure transducer870.2880超聲式傳感器ultrasonic transducer870

12、.2890脈管閉塞傳感器vessel occlusion transducer870.2900患者傳感器和電極電纜（包括連接器）patient transducer and electrode cable （including connector）870.2910射頻生理信號發(fā)送器和接收器radiofrequency physiological signal transmitter and receiver870.2920電話式心電圖儀發(fā)送器和接收器telephone electrocardiograph transmitter and receiverd亞部心血管修復(fù)器械（cardiovas

13、cular prosthetic devices）870.3250血管夾vascular clip870.3260腔靜脈夾vena cava clip870.3300動脈栓塞器械arterial embolization device870.3375心血管內(nèi)過濾器cardiovascular intravascular filter870.3450血管移植假體vascular graft prosthesis870.3470聚丙烯、聚對苯二甲酸乙酯或聚四氟乙烯制成的心內(nèi)補片或紗布intracardiac patch or pledget made of polypropylene, polye

14、thylene terephthalate, or polytetrafluoroethylene870.3535大動脈內(nèi)球囊和控制系統(tǒng)intra-aortic balloon and control system870.3545心室旁路（輔助）器械ventricular bypass （assist） device870.3600體外起搏器脈沖發(fā)生器external pacemaker pulse generator870.3610植入式起搏器脈沖發(fā)生器implantable pacemaker pulse generator870.3620起搏器導(dǎo)線接合器pacemaker lead ad

15、aptor870.3630起搏器發(fā)生器功能分析儀pacemaker generator function analyzer870.3640間接式起搏器發(fā)生器功能分析儀indirect pacemaker generator function analyzer870.3650起搏器聚合體網(wǎng)袋pacemaker polymeric mesh bag870.3670起搏器充電器pacemaker charger870.3680心血管永久性或臨時性起搏器電極cardiovascular permanent or temporary pacemaker electrode870.3690起搏器測試磁鐵p

16、acemaker test magnet870.3700起搏器程序器pacemaker programmers870.3710起搏器修復(fù)或替換材料pacemaker repair or replacement material870.3720起搏器電極功能檢測器pacemaker electrode function tester870.3730起搏器維修工具pacemaker service tools870.3800瓣環(huán)成形術(shù)環(huán)annuloplasty ring870.3850頸動脈竇神經(jīng)刺激器carotid sinus nerve stimulator870.3925心臟瓣膜替代品rep

17、lacement heart valve870.3935心臟瓣膜假體支架prosthetic heart valve holder870.3945心臟瓣膜假體篩選器prosthetic heart valve sizere亞部心血管手術(shù)器械（cardiovascular surgical devices）870.4075心肌膜炎活組織檢查器械endomyocardial biopsy device870.4200心肺旁路附屬設(shè)備cardiopulmonary bypass accessory equipment870.4205心肺旁路氣泡探測器cardiopulmonary bypass bu

18、bble detector870.4210心肺旁路血管導(dǎo)管、套管或管路cardiopulmonary bypass vascular catheter, cannula, or tubing870.4220心肺旁路心肺機控制臺cardiopulmonary bypass heart-lung machine console870.4230心肺旁路消泡器cardiopulmonary bypass defoamer870.4240心肺旁路熱交換器cardiopulmonary bypass heat exchanger870.4250心肺旁路溫度控制器cardiopulmonary bypass

19、 temperature controller870.4260心肺旁路動脈血過濾器cardiopulmonary bypass arterial line blood filter870.4270心肺旁路心切開術(shù)抽吸管路血液過濾器cardiopulmonary bypass cardiotomy suction line blood filter870.4280心肺旁路前過濾器cardiopulmonary prebypass filter870.4290心肺旁路接合器、旋塞閥、匯流管或配件cardiopulmonary bypass adaptor, stopcock, manifold,

20、or fitting870.4300 心肺旁路氣體控制裝置cardiopulmonary bypass gas control unit870.4310心肺旁路冠狀動脈壓力計cardiopulmonary bypass coronary pressure gauge870.4320心肺旁路脈動流發(fā)生器cardiopulmonary bypass pulsatile flow generator870.4330心肺旁路即時血氣監(jiān)測儀cardiopulmonary bypass on-line blood gas monitor870.4340心肺旁路液面自動檢測監(jiān)視器和/或控制器cardiopu

21、lmonary bypass level sensing monitor and/or control870.4350心肺旁路氧合器cardiopulmonary bypass oxygenator870.4360非滾筒型心肺旁路血液泵nonroller-type cardiopulmonary bypass blood pump870.4370滾筒型心肺旁路血液泵roller-type cardiopulmonary bypass blood pump870.4380心肺旁路泵速度控制器cardiopulmonary bypass pump speed control870.4390心肺旁路泵管路cardiopulmonary bypass pump tubing870.4400心肺旁路血液儲存器cardiopu