A亞部——總則（General Provisions）
    870.1
    范圍
    Scope
    870.3
    有關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
    診斷用血管內導管
    Diagnostic intravascular catheter
    870.1210
    連續(xù)式沖洗導管
    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
    經皮導管
    Percutaneous catheter
    870.1270
    腔內心音導管系統(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節(jié)器
    Biopotential amplifier and signal conditioner
    870.2060
    傳感器信號放大器和調節(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
    Arterial embolization device
    870.3375
    心血管內過濾器
    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補片或紗布
    Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
    870.3535
    大動脈內球囊和控制系統(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)成形術環(huán)
    Annuloplasty ring
    870.3850
    頸動脈竇神經刺激器
    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
    心肺旁路內嵌式血氣傳感器
    Cardiopulmonary bypass in-line blood gas sensor
    870.4420
    心肺旁路心切開術返回吸管
    Cardiopulmonary bypass cardiotomy return sucker
    870.4430
    心肺旁路心臟內抽吸控制器
    Cardiopulmonary bypass intracardiac suction control
    870.4450
    血管夾
    Vascular clamp
    870.4475
    外科手術血管擴張器
    Surgical vessel dilator
    870.4500
    心血管手術器具
    Cardiovascular surgical instruments
    870.4875
    管腔內動脈剝離器
    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）
    DC