A亞部——總則（General Provisions）

　　870.1范圍Scope

　　870.3有關(guān)上市前批準生效日期的要求Effective dates of requirement for premarket approval

　　870.9聯(lián)邦食品、藥品和化妝品法（Federal Food， Drug， and Cosmetic Act，F(xiàn)DCA）第510（k）節(jié)的豁免限制Limitations of exemptions from section 510（k） of the 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 alarm

　　870.1110血壓計算機Blood pressure computer

　　870.1120血壓袖帶Blood pressure cuff

　　870.1130非侵入式血壓測量系統(tǒng)Noninvasive blood pressure measurement system

　　870.1140靜脈血壓計Venous blood pressure manometer

　　870.1200診斷用血管內(nèi)導管Diagnostic intravascular catheter

　　870.1210連續(xù)式?jīng)_洗導管Continuous flush catheter

　　870.1220電極記錄導管或電極記錄探針Electrode recording catheter or electrode recording probe

　　870.1230光纖式血氧計導管Fiberoptic oximeter catheter

　　870.1240導流導管Flow-directed catheter

　　870.1250經(jīng)皮導管Percutaneous catheter

　　870.1270腔內(nèi)心音導管系統(tǒng)Intracavitary phonocatheter system

　　870.1280可操縱導管Steerable catheter

　　870.1290可操縱導管控制系統(tǒng)Steerable catheter control system

　　870.1300導管套管Catheter cannula

　　870.1310經(jīng)皮插入導管用的血管擴張器Vessel dilator for percutaneous catheterization

　　870.1330導管導線Catheter guide wire

　　870.1340導管插入器Catheter introducer

　　870.1350導管球囊修理工具盒Catheter balloon repair kit

　　870.1360示蹤微球體Trace microsphere

　　870.1370導管尖端封閉器Catheter tip occluder

　　870.1380導管探針Catheter stylet

　　870.1390套管針Trocar

　　870.1425可編程的診斷用計算機Programmable diagnostic computer

　　870.1435預編程的單功能診斷用計算機Single-function， preprogrammed diagnostic computer

　　870.1450光密度計Densitometer

　　870.1650血管造影注射器和注射管Angiographic injector and syringe

　　870.1660指示劑注射器Indicator injector

　　870.1670注射器的注射管制動器Syringe actuator for an injector

　　870.1750體外可編程起搏器脈沖發(fā)生器External programmable pacemaker pulse generator

　　870.1800抽縮式輸液泵Withdrawal-infusion pump

　　870.1875聽診器Stethoscope

　　870.1915熱稀釋探頭Thermodilution probe

　　C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 conditioner

　　870.2060傳感器信號放大器和調(diào)節(jié)器Transducer signal amplifier and conditioner

　　870.2100心血管血液流量計Cardiovascular blood flowmeter

　　870.2120血管外血流探頭Extravascular blood flow probe

　　870.2300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Ballistocardiograph

　　870.2330超聲波心動圖儀Echocardiograph

　　870.2340心電圖儀Electrocardiograph

　　870.2350心電圖儀導線轉(zhuǎn)換接合器Electrocardiograph lead switching adaptor

　　870.2360心電圖儀電極Electrocardiograph electrode

　　870.2370心電圖儀表面電極檢測器Electrocardiograph surface electrode tester

　　870.2390心音圖儀Phonocardiograph

　　870.2400心電向量圖儀Vectorcardiograph

　　870.2450醫(yī)用陰極射線管顯示器Medical cathode-ray tube display

　　870.2600信號隔離系統(tǒng)Signal isolation system

　　870.2620在線隔離監(jiān)視器Line isolation monitor

　　870.2640便攜式漏電流警報器Portable leakage current alarm

　　870.2675動脈搏動描記器Oscillometer

　　870.2700光電血氧計Oximeter

　　870.2710耳光電血氧計Ear oximeter

　　870.2750阻抗式靜脈搏動描記器Impedance phlebograph

　　870.2770阻抗式體積描記器Impedance plethysmograph

　　870.2780水壓式、氣動式或光電式體積描記器Hydraulic， pneumatic， or photoelectric plethysmographs

　　870.2800醫(yī)用磁帶記錄器Medical magnetic tape recorder

　　870.2810紙質(zhì)圖表記錄器Paper chart recorder

　　870.2840尖端心動描記傳感器Apex cardiographic transducer

　　870.2850血管外血壓傳感器Extravascular blood pressure transducer

　　870.2860心音傳感器Heart sound transducer

　　870.2870導管頂端壓力傳感器Catheter tip pressure transducer

　　870.2880超聲式傳感器Ultrasonic transducer

　　870.2890脈管閉塞傳感器Vessel occlusion transducer

　　870.2900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 receiver

　　870.2920電話式心電圖儀發(fā)送器和接收器Telephone electrocardiograph transmitter and receiver

　　D亞部——心血管修復器械（Cardiovascular Prosthetic Devices）

　　870.3250血管夾Vascular clip

　　870.3260腔靜脈夾Vena cava clip

　　870.3300動脈栓塞器械A(chǔ)rterial embolization device

　　870.3375心血管內(nèi)過濾器Cardiovascular intravascular filter

　　870.3450血管移植假體Vascular graft prosthesis

　　870.3470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， polyethylene terephthalate， or polytetrafluoroethylene

　　870.3535大動脈內(nèi)球囊和控制系統(tǒng)Intra-aortic balloon and control system

　　870.3545心室旁路（輔助）器械Ventricular bypass （assist） device

　　870.3600體外起搏器脈沖發(fā)生器External pacemaker pulse generator

　　870.3610植入式起搏器脈沖發(fā)生器Implantable pacemaker pulse generator

　　870.3620起搏器導線接合器Pacemaker lead adaptor

　　870.3630起搏器發(fā)生器功能分析儀Pacemaker generator function analyzer

　　870.3640間接式起搏器發(fā)生器功能分析儀Indirect pacemaker generator function analyzer

　　870.3650起搏器聚合體網(wǎng)袋Pacemaker polymeric mesh bag

　　870.3670起搏器充電器Pacemaker charger

　　870.3680心血管永久性或臨時性起搏器電極Cardiovascular permanent or temporary pacemaker electrode

　　870.3690起搏器測試磁鐵Pacemaker test magnet

　　870.3700起搏器程序器Pacemaker programmers

　　870.3710起搏器修復或替換材料Pacemaker repair or replacement material

　　870.3720起搏器電極功能檢測器Pacemaker electrode function tester

　　870.3730起搏器維修工具Pacemaker service tools

　　870.3800瓣環(huán)成形術(shù)環(huán)Annuloplasty ring

　　870.3850頸動脈竇神經(jīng)刺激器Carotid sinus nerve stimulator

　　870.3925心臟瓣膜替代品Replacement heart valve

　　870.3935心臟瓣膜假體支架Prosthetic heart valve holder

　　870.3945心臟瓣膜假體篩選器Prosthetic heart valve sizer

　　E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 device

　　870.4200心肺旁路附屬設(shè)備Cardiopulmonary bypass accessory equipment

　　870.4205心肺旁路氣泡探測器Cardiopulmonary bypass bubble detector

　　870.4210心肺旁路血管導管、套管或管路Cardiopulmonary bypass vascular catheter， cannula， or tubing

　　870.4220心肺旁路心肺機控制臺Cardiopulmonary bypass heart-lung machine console

　　870.4230心肺旁路消泡器Cardiopulmonary bypass defoamer

　　870.4240心肺旁路熱交換器Cardiopulmonary bypass heat exchanger

　　870.4250心肺旁路溫度控制器Cardiopulmonary bypass temperature controller

　　870.4260心肺旁路動脈血過濾器Cardiopulmonary bypass arterial line blood filter

　　870.4270心肺旁路心切開術(shù)抽吸管路血液過濾器Cardiopulmonary bypass cardiotomy suction line blood filter

　　870.4280心肺旁路前過濾器Cardiopulmonary prebypass filter

　　870.4290心肺旁路接合器、旋塞閥、匯流管或配件Cardiopulmonary bypass adaptor， stopcock， manifold， or fitting

　　870.4300心肺旁路氣體控制裝置Cardiopulmonary bypass gas control unit

　　870.4310心肺旁路冠狀動脈壓力計Cardiopulmonary bypass coronary pressure gauge

　　870.4320心肺旁路脈動流發(fā)生器Cardiopulmonary bypass pulsatile flow generator

　　870.4330心肺旁路即時血氣監(jiān)測儀Cardiopulmonary bypass on-line blood gas monitor

　　870.4340心肺旁路液面自動檢測監(jiān)視器和/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非滾筒型心肺旁路血液泵Nonroller-type cardiopulmonary bypass blood pump

　　870.4370滾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心肺旁路血液儲存器Cardiopulmonary bypass blood reservoir

　　870.4410心肺旁路內(nèi)嵌式血氣傳感器Cardiopulmonary bypass in-line blood gas sensor

　　870.4420心肺旁路心切開術(shù)返回吸管Cardiopulmonary bypass cardiotomy return sucker

　　870.4430心肺旁路心臟內(nèi)抽吸控制器Cardiopulmonary bypass intracardiac suction control

　　870.4450血管夾Vascular clamp

　　870.4475外科手術(shù)血管擴張器Surgical vessel dilator

　　870.4500心血管手術(shù)器具Cardiovascular surgical instruments

　　870.4875管腔內(nèi)動脈剝離器Intraluminal artery stripper

　　870.4885體外靜脈剝離器External vein stripper

　　F亞部 ——心血管治療器械（Cardiovascular Therapeutic Devices）

　　870.5050患者照料吸引裝置Patient care suction apparatus

　　870.5150栓子切除導管Embolectomy catheter

　　870.5175房隔造口導管Septostomy catheter

　　870.5200體外心臟擠壓器External cardiac compressor

　　870.5225體外反搏裝置External counter-pulsating device

　　870.5300 DC－除顫器（包括除顫板）