21 CFR Part 870

179 regulation numbers covering 344 product codes in 21 CFR Part 870.

Regulations

179

Product Codes

344

21 CFR Part 870 Regulations

179 entries

Regulation Number	Product Codes	Device Name	Class
870.1025	QYW, DSI, QYX, MXD, MHX +1 more	Hospital Cardiac Telemetry	Class II
870.1100	DSJ	Alarm, Blood-Pressure	Class II
870.1110	DSK	Computer, Blood-Pressure	Class II
870.1120	OED, DXQ, NPP	Antimicrobial Blood Pressure Cuff	Class II
870.1130	DXN, QYF	System, Measurement, Blood-Pressure, Non-Invasive	Class II
870.1135	QXY	Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature	Class II
870.1140	OFF, PFA, OFE, KRK	Central Venous Catheter Tray	Class II
870.1150	SIF	Software Device System For Estimation Of Cardiac Pressures	Class II
870.1200	OES, NUI, OBI, OEZ, DQO +6 more	Cardiac Catheterization Kit	Class II
870.1210	NPG, KRA	Catheter, Infusion, Syringe	Class II
870.1220	NLG, NLH, DRF, MTD	Catheter, Intracardiac Mapping, High-Density, Reprocessed	Class II
870.1230	NMB, DQE	Catheter, Oximeter, Fiber Optic, Reprocessed	Class II
870.1240	DYG	Catheter, Flow Directed	Class II
870.1250	NMM, DQY, PDU, NRY, OMZ +8 more	Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed	Class II
870.1251	PUM	Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	Class II
870.1252	PQK	Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access	Class II
870.1254	SCZ, SGO	Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures	Class II
870.1255	OZT	Balloon Aortic Valvuloplasty	Class II
870.1270	DXW	System, Phonocatheter, Intracavitary	Class II
870.1280	NKS, DRA	Catheter, Steerable, Reprocessed	Class II
870.1290	DXX, NDQ, NKR	System, Catheter Control, Steerable	Class II
870.1300	DQR	Cannula, Catheter	Class II
870.1310	DRE	Dilator, Vessel, For Percutaneous Catheterization	Class II
870.1330	PTL, OFB, DQX, MOF, NKQ	Wire, Guide, Catheter, Exempt	Class II
870.1340	OFD, DYB, OFL, OFC, OFJ +2 more	Catheter Introducer Kit	Class II
870.1342	QJH	Reverse Central Venous Recanalization System	Class II
870.1345	QFJ	Intravascular Bleed Monitor	Class II
870.1350	DQP	Kit, Balloon Repair, Catheter	Class III
870.1360	DQG	Microsphere, Trace	Class III
870.1370	DQT	Occluder, Catheter Tip	Class II
870.1380	DRB	Stylet, Catheter	Class II
870.1390	NMK, DRC	Trocar, Reprocessed	Class II
870.1405	QQI	Interventional Cardiovascular Implant Simulation Software Device	Class II
870.1415	PJA, QEK	Coronary Vascular Physiologic Simulation Software	Class II
870.1420	QMW	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals	Class II
870.1425	DQK	Computer, Diagnostic, Programmable	Class II
870.1435	DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Class II
870.1450	DXM	Densitometer	Class II
870.1650	OEQ, NKU, IZQ, NKP, OFH +5 more	Angiography/Angioplasty Kit	Class II
870.1660	DXL	Injector, Indicator	Class II
870.1670	DQF, NKW	Actuator, Syringe, Injector Type	Class II
870.1750	JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)	Class II
870.1800	DQI	Withdrawal/Infusion Pump	Class II
870.1875	DQD, LDE, QBE, OCR	Stethoscope, Electronic	Class I Class II
870.1915	KRB	Probe, Thermodilution	Class II
870.2050	DRR	Amplifier And Signal Conditioner, Biopotential	Class II
870.2060	DRQ	Amplifier And Signal Conditioner, Transducer Signal	Class II
870.2100	DPW	Flowmeter, Blood, Cardiovascular	Class II
870.2120	DPT, OFI	Probe, Blood-Flow, Extravascular	Class II
870.2200	SDJ, QXZ, PPW, QUO	Adjunctive Cardiac Amyloidosis Status Indicator	Class II
870.2210	QAQ, QNL	Adjunctive Predictive Cardiovascular Indicator	Class II
870.2220	QNV, SAR	Adjunctive Hemodynamic Indicator With Decision Point	Class II
870.2300	PLB, DRT, MWI, PFY, MSX	Multivariate Vital Signs Index	Class II
870.2310	DQH	Cardiograph, Apex (Vibrocardiograph)	Class II
870.2320	DXR	Ballistocardiograph	Class II
870.2330	DXK	Echocardiograph	Class II
870.2340	DPS, MLC	Electrocardiograph	Class II
870.2345	QDA	Electrocardiograph Software For Over-The-Counter Use	Class II
870.2350	DRW	Adaptor, Lead Switching, Electrocardiograph	Class II
870.2360	DRX, MLN	Electrode, Electrocardiograph	Class II
870.2370	KRC	Tester, Electrode, Surface, Electrocardiographic	Class II
870.2380	SBQ, QXO, SHP, SAT, QXX +2 more	Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software	Class II
870.2390	DQC	Phonocardiograph	Class I
870.2400	DYC	Vectorcardiograph	Class II
870.2450	DXJ	Display, Cathode-Ray Tube, Medical	Class II
870.2600	DRJ	System, Signal Isolation	Class I
870.2620	DRI	Monitor, Line Isolation	Class I
870.2640	DSM	Alarm, Leakage Current, Portable	Class I
870.2675	DRZ	Oscillometer	Class II
870.2700	OLK, NLF, MUD, PGJ, NMD +3 more	Pulse Oximeter For Over-The-Counter Use	Class II
870.2705	QYU	Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use	Class II
870.2710	DPZ	Oximeter, Ear	Class II
870.2720	QWE	Hyperoxia Monitoring Device Adjunct To Pulse Oximetry	Class II
870.2750	DQB, OFM	Phlebograph, Impedance	Class II
870.2770	DSB, OBH, OAC, QJB, OMV +3 more	Plethysmograph, Impedance	Class II
870.2780	JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Class II
870.2785	QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate	Class II
870.2786	QOK	Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate	Class II
870.2790	SDY, QDB	Loss Of Pulse Notification Software	Class II
870.2800	MWJ, MLO, DSH, MXC	Electrocardiograph, Ambulatory (Without Analysis)	Class II
870.2810	DSF	Recorder, Paper Chart	Class I
870.2840	JON	Transducer, Apex Cardiographic	Class II
870.2850	DRS	Transducer, Blood-Pressure, Extravascular	Class II
870.2855	NQH	Sensor, Pressure, Aneurysm, Implantable	Class II
870.2860	JOO	Transducer, Heart Sound	Class II
870.2870	DXO	Transducer, Pressure, Catheter Tip	Class II
870.2880	JOP	Transducer, Ultrasonic	Class II
870.2890	DXP	Transducer, Vessel Occlusion	Class II
870.2900	DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Class II
870.2910	DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Class II
870.2920	DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Class II
870.3250	DSS	Clip, Vascular	Class II
870.3260	DST	Clip, Vena-Cava	Class II
870.3300	NAJ, KRD	Agents, Embolic, For Treatment Of Uterine Fibroids	Class II
870.3325	QZU	Temporary Embolization Assist Device, Peripheral	Class II
870.3375	PNS, DTK	Short-Term Intravascular Filter Catheter	Class II
870.3450	DSY, MAB, DYF, MAL, MZY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Class II
870.3460	OTD	Endovascular Suturing System	Class II
870.3470	PAW, MFX, OMR, OMH, PSQ +1 more	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	Class II
870.3490	SBK	Artificial Chordae Tendineae Surgical Replacement System	Class II
870.3535	DSP, NKO	System, Balloon, Intra-Aortic And Control	Class II Class III
870.3545	OKR, PCK	Ventricular Bypass (Assist) Device	Class III
870.3600	DTE, OVJ	Pulse-Generator, Pacemaker, External	Class II
870.3605	QAB	Pacing System Analyzer	Class II
870.3610	DXY, PNJ, DSZ	Implantable Pacemaker Pulse-Generator	Class III
870.3620	DTD	Pacemaker Lead Adaptor	Class II
870.3630	DTC	Analyzer, Pacemaker Generator Function	Class II
870.3640	KRE	Analyzer, Pacemaker Generator Function, Indirect	Class II
870.3650	DSW	Bag, Polymeric Mesh, Pacemaker	Class I
870.3670	KRF	Charger, Pacemaker	Class I
870.3680	LDF, NHW, DTB	Electrode, Pacemaker, Temporary	Class II Class III
870.3690	DTG	Magnet, Test, Pacemaker	Class I
870.3700	KRG	Programmer, Pacemaker	Class III
870.3710	KFJ	Materials, Repair Or Replacement, Pacemaker	Class III
870.3720	DTA	Tester, Pacemaker Electrode Function	Class II
870.3730	DTF	Tools, Pacemaker Service	Class I
870.3800	PST, KRH	Aortic Annuloplasty Ring	Class II
870.3850	DSR	Stimulator, Carotid Sinus Nerve	Class III
870.3925	DYE, PAL	Replacement Heart-Valve	Class III
870.3935	DTJ, MOP	Holder, Heart-Valve, Prosthesis	Class I
870.3945	DTI	Sizer, Heart-Valve, Prosthesis	Class I
870.3955	QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Class I
870.4075	OFG, DWZ, MFY	Ct Biopsy Tray	Class II
870.4100	QWF, BYS, QJZ, QHW, PZS +1 more	Tubing, Long Term Support Greater Than 6 Hours	Class II
870.4150	QOH	Extracorporeal System For Carbon Dioxide Removal	Class II
870.4200	KRI	Accessory Equipment, Cardiopulmonary Bypass	Class I
870.4205	KRL	Detector, Bubble, Cardiopulmonary Bypass	Class II
870.4210	OEU, DWF	Cardiopulmonary Bypass Catheter Kit	Class II
870.4220	DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Class II
870.4230	DTP	Defoamer, Cardiopulmonary Bypass	Class II
870.4240	OET, DTR	Cardioplegia Solution Administration Kit	Class II
870.4250	DWC	Controller, Temperature, Cardiopulmonary Bypass	Class II
870.4260	DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Class II
870.4270	JOD	Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass	Class II
870.4280	KRJ	Filter, Prebypass, Cardiopulmonary Bypass	Class II
870.4290	DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Class II
870.4300	DTX	Gas Control Unit, Cardiopulmonary Bypass	Class II
870.4310	DXS	Gauge, Pressure, Coronary, Cardiopulmonary Bypass	Class II
870.4320	JOR	Generator, Pulsatile Flow, Cardiopulmonary Bypass	Class III
870.4330	DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Class II
870.4340	DTW	Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass	Class II
870.4350	DTZ	Oxygenator, Cardiopulmonary Bypass	Class II
870.4360	PYX, KFM	Temporary Non-Roller Type Right Heart Support Blood Pump	Class II Class III
870.4370	DWB	Pump, Blood, Cardiopulmonary Bypass, Roller Type	Class II
870.4380	DWA	Control, Pump Speed, Cardiopulmonary Bypass	Class II
870.4390	DWE	Tubing, Pump, Cardiopulmonary Bypass	Class II
870.4400	PTN, MNJ, MJJ, DTN	Reservoir, Blood, Cardiopulmonary Bypass, Exempt	Class II
870.4410	DTY	Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass	Class II
870.4420	DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Class II
870.4430	DWD	Suction Control, Intracardiac, Cardiopulmonary Bypass	Class II
870.4450	DXC, MJN, NMF	Clamp, Vascular	Class II
870.4475	DWP	Dilator, Vessel, Surgical	Class II
870.4500	NQG, OFA, MWS, LXN, DWS	Stabilizer, Heart, Non-Compression, Reprocessed	Class I
870.4510	PNQ	Apical Closure Device	Class II
870.4520	SHR	Device For Open Surgical Explant Of Endovascular Prostheses	Class II
870.4600	QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access	Class II
870.4875	QTF, DWX, MCW	Reprocessed Atherectomy Catheter	Class II
870.4885	DWQ, NLJ, MGZ	Stripper, Vein, External	Class II
870.5050	DWM	Apparatus, Suction, Patient Care	Class II
870.5100	LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Class II
870.5110	SEU	Peripheral Temporary And Retrievable Stent System	Class II
870.5125	QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	Class II
870.5150	DXE, QEX, QEY, MMX, QEW +1 more	Catheter, Embolectomy	Class II
870.5175	QLZ, DXF	Septostomy Catheter, Reprocessed	Class II
870.5200	DRM	Compressor, Cardiac, External	Class II
870.5210	LIX, PMK, PMJ	Aid, Cardiopulmonary Resuscitation	Class I Class II
870.5225	DRN	Device, Counter-Pulsating, External	Class II
870.5300	MPC, LDD, MPD, DRK	Atrial Defibrillator	Class II Class III
870.5310	NSA, MKJ	Over-The-Counter Automated External Defibrillator	Class III
870.5325	DRL	Tester, Defibrillator	Class II
870.5550	DRO, MPE	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Class II
870.5600	QMS	Adjunctive Open Loop Fluid Therapy Recommender	Class II
870.5700	PJB	Catheter Remote Control System	Class II
870.5710	QXU	Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation	Class II
870.5720	QXV	Temperature Regulation Device For Esophageal Protection During Cardiac Ablation	Class II
870.5800	JOW, LHX, PPS	Sleeve, Limb, Compressible	Class II
870.5900	NCX, DWJ, NZE	System, Hypothermia, Intravenous, Cooling	Class II
870.5910	PLA	Esophageal Thermal Regulation And Gastric Suctioning Device	Class II
870.5925	DRP	Tourniquet, Automatic Rotating	Class II