A亞部——總則（General Provisions）

　　870.1范圍Scope

　　870.3有關(guān)上市前批準(zhǔn)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(bào)器（包括ST段測量和警報(bào)）

　　Arrhythmia detector and alarm （including ST-segment measurement and alarm）

　　870.1100血壓警報(bào)器Blood pressure alarm

　　870.1110血壓計(jì)算機(jī)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(jì)Venous blood pressure manometer

　　870.1200診斷用血管內(nèi)導(dǎo)管Diagnostic intravascular catheter

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

　　870.1220電極記錄導(dǎo)管或電極記錄探針Electrode recording catheter or electrode recording probe

　　870.1230光纖式血氧計(jì)導(dǎo)管Fiberoptic oximeter catheter

　　870.1240導(dǎo)流導(dǎo)管Flow-directed catheter

　　870.1250經(jīng)皮導(dǎo)管Percutaneous catheter

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

　　870.1280可操縱導(dǎo)管Steerable catheter

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

　　870.1300導(dǎo)管套管Catheter cannula

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

　　870.1330導(dǎo)管導(dǎo)線Catheter guide wire

　　870.1340導(dǎo)管插入器Catheter introducer

　　870.1350導(dǎo)管球囊修理工具盒Catheter balloon repair kit

　　870.1360示蹤微球體Trace microsphere

　　870.1370導(dǎo)管尖端封閉器Catheter tip occluder

　　870.1380導(dǎo)管探針Catheter stylet

　　870.1390套管針Trocar

　　870.1425可編程的診斷用計(jì)算機(jī)Programmable diagnostic computer

　　870.1435預(yù)編程的單功能診斷用計(jì)算機(jī)Single-function， preprogrammed diagnostic computer

　　870.1450光密度計(jì)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(dòng)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(hào)調(diào)節(jié)器Biopotential amplifier and signal conditioner

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

　　870.2100心血管血液流量計(jì)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(jì)和心率警報(bào)器）

　　Cardiac monitor （including cardiotachometer and rate alarm）

　　870.2310尖端心動(dòng)描記器（心振動(dòng)圖儀）

　　Apex cardiograph （vibrocardiograph）

　　870.2320心沖擊描記器Ballistocardiograph

　　870.2330超聲波心動(dòng)圖儀Echocardiograph

　　870.2340心電圖儀Electrocardiograph

　　870.2350心電圖儀導(dǎo)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(hào)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(bào)器Portable leakage current alarm

　　870.2675動(dòng)脈搏動(dòng)描記器Oscillometer

　　870.2700光電血氧計(jì)Oximeter

　　870.2710耳光電血氧計(jì)Ear oximeter

　　870.2750阻抗式靜脈搏動(dòng)描記器Impedance phlebograph

　　870.2770阻抗式體積描記器Impedance plethysmograph

　　870.2780水壓式、氣動(dòng)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(dòng)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(dǎo)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(hào)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(fù)器械（Cardiovascular Prosthetic Devices）

　　870.3250血管夾Vascular clip

　　870.3260腔靜脈夾Vena cava clip

　　870.3300動(dòng)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(duì)苯二甲酸乙酯或聚四氟乙烯制成的心內(nèi)補(bǔ)片或紗布Intracardiac patch or pledget made of polypropylene， polyethylene terephthalate， or polytetrafluoroethylene

　　870.3535大動(dòng)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）醫(yī).學(xué)教.育網(wǎng)搜.集整理器械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(dǎo)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(shí)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(fù)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(dòng)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(dǎo)管、醫(yī)學(xué)教.育網(wǎng)搜集套管或管路Cardiopulmonary bypass vascular catheter， cannula， or tubing

　　870.4220心肺旁路心肺機(jī)控制臺(tái)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(dòng)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(dòng)脈壓力計(jì)Cardiopulmonary bypass coronary pressure gauge

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

　　870.4330心肺旁路即時(shí)血?dú)獗O(jiān)測儀Cardiopulmonary bypass on-line blood gas monitor

　　870.4340心肺旁路液面自動(dòng)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(chǔ)存器Cardiopulmonary bypass blood reservoir

　　870.4410心肺旁路內(nèi)嵌式血?dú)鈧鞲衅鰿ardiopulmonary 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(kuò)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(dòng)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(dǎo)管Embolectomy catheter

　　870.5175房隔造口導(dǎo)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）