FDA Device Explorer

Cardiovascular (CV) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Cardiovascular (CV) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 862, Part 870, Part 892

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
OJQCardiac Allograft Gene Expression Profiling Test System862.116322
DSIDetector And Alarm, Arrhythmia870.10252398
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)870.10252421
MLDMonitor, St Segment With Alarm870.1025214
MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)870.1025232
QYWHospital Cardiac Telemetry870.102522
QYXOutpatient Cardiac Telemetry870.1025220
DSJAlarm, Blood-Pressure870.110026
DSKComputer, Blood-Pressure870.1110277
DXQBlood Pressure Cuff870.11202197
NPPReprocessed Blood Pressure Cuff870.112021
OEDAntimicrobial Blood Pressure Cuff870.112022
DXNSystem, Measurement, Blood-Pressure, Non-Invasive870.113021207
QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)870.113020
QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature870.113521
KRKManometer, Blood-Pressure, Venous870.114029
OFECentral Venous Blood Pressure Kit870.114020
OFFCentral Venous Catheter Tray870.114020
PFANon-Invasive Central Venous Manometer870.114022
DQOCatheter, Intravascular, Diagnostic870.12002499
NLICatheter, Angiography, Reprocessed870.120021
NUIUltrasound, Infusion, System870.120024
OBICatheter, Pressure Monitoring, Cardiac870.120021
OBJCatheter, Ultrasound, Intravascular870.1200278
OESCardiac Catheterization Kit870.120020
OEZCardiovascular Procedure Kit870.120020
OFNWinged Intravenous Catheterization Kit870.120020
OGZCatheter, Intravascular, Plaque Morphology Evaluation870.120029
ORDOptical Coherence Tomography, Intravascular Catheter870.120020
OWQReprocessed Intravascular Ultrasound Catheter870.1200230
KRACatheter, Continuous Flush870.12102173
NPGCatheter, Infusion, Syringe870.121021
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording870.12202186
MTDCatheter, Intracardiac Mapping, High-Density Array870.1220233
NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed870.122023
NLHCatheter, Recording, Electrode, Reprocessed870.1220270
DQECatheter, Oximeter, Fiber-Optic870.1230219
NMBCatheter, Oximeter, Fiber Optic, Reprocessed870.123020
DYGCatheter, Flow Directed870.1240299
DQYCatheter, Percutaneous870.12502887
LITCatheter, Angioplasty, Peripheral, Transluminal870.12502402
NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection870.1250222
NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed870.125020
NRYCatheter, Thrombus Retriever870.12502106
NTETemporary Carotid Catheter For Embolic Capture870.1250236
NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon870.125025
OFKPercutaneous Atrial Catheter Kit870.125020
OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter870.125025
PDUCatheter For Crossing Total Occlusions870.1250257
PNOCatheter, Percutaneous, Cutting/Scoring870.1250245
PPNPercutaneous Catheter, Ultrasound870.1250212
QJPCatheter, Percutaneous, Neurovasculature870.1250288
PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures870.125122
PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access870.125227
SCZPercutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures870.125421
SGOPercutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures870.125421
OZTBalloon Aortic Valvuloplasty870.1255221
DXWSystem, Phonocatheter, Intracavitary870.127025
DRACatheter, Steerable870.1280241
NKSCatheter, Steerable, Reprocessed870.128020
DXXSystem, Catheter Control, Steerable870.1290233
NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)870.129022
NKRSystem, Catheter Control, Reprocessed870.129020
DQRCannula, Catheter870.1300225
DREDilator, Vessel, For Percutaneous Catheterization870.13102104
DQXWire, Guide, Catheter870.13302763
MOFGuide, Wire, Catheter, Neurovasculature870.1330239
NKQGuidewire, Catheter, Reprocessed870.133020
OFBCatheter Guide Wire Kit870.133020
PTLWire, Guide, Catheter, Exempt870.133020
DYBIntroducer, Catheter870.13402699
OEXCardiovascular Catheter Sheath Introducer Kit870.134020
OFCCatheter Introducer Kit870.134021
OFDCatheter Introducer Kit870.134020
OFJLead Introducer Kit870.134020
OFLPercutaneous Sheath Introducer Kit870.134020
PNEReprocessed Catheter Introducer870.134027
QJHReverse Central Venous Recanalization System870.134222
QFJIntravascular Bleed Monitor870.134522
DQPKit, Balloon Repair, Catheter870.135030
DQGMicrosphere, Trace870.136030
DQTOccluder, Catheter Tip870.1370212
DRBStylet, Catheter870.1380228
DRCTrocar870.1390251
NMKTrocar, Reprocessed870.139021
QQIInterventional Cardiovascular Implant Simulation Software Device870.140524
PJACoronary Vascular Physiologic Simulation Software870.141529
QEKAngiographic Coronary Vascular Physiologic Simulation Software870.141522
QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals870.142021
DQKComputer, Diagnostic, Programmable870.14252426
DXGComputer, Diagnostic, Pre-Programmed, Single-Function870.14352177
DXMDensitometer870.145022
DXTInjector And Syringe, Angiographic870.16502207
IZQInjector, Contrast Medium, Automatic870.1650222
MAVSyringe, Balloon Inflation870.1650257
NKPInjector, Contrast Medium, Automatic, Reprocessed870.165020
NKTInjector And Syringe, Angiographic, Reprocessed870.165020
NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed870.165021
OEQAngiography/Angioplasty Kit870.165020
OERAngioscopic Valvulotome Kit870.165020
OFHDigital Angiography Tray870.165020
PTMSyringe, Balloon Inflation, Exempt870.165020
DXLInjector, Indicator870.166023
DQFActuator, Syringe, Injector Type870.167023
NKWActuator, Syringe, For Injector, Reprocessed870.167020
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)870.1750219
DQIWithdrawal/Infusion Pump870.180029
DQDStethoscope, Electronic870.18752153
LDEStethoscope, Manual870.1875128
OCRLung Sound Monitor870.187523
QBECranial Sound Monitor870.187521
KRBProbe, Thermodilution870.1915237
DRRAmplifier And Signal Conditioner, Biopotential870.2050224
DRQAmplifier And Signal Conditioner, Transducer Signal870.2060227
DPWFlowmeter, Blood, Cardiovascular870.21002136
DPTProbe, Blood-Flow, Extravascular870.2120248
OFILaser Blood Flow Kit870.212020
PPWAdjunctive Cardiovascular Status Indicator870.220028
QUOAdjunctive Heart Failure Status Indicator870.220024
QXZAdjunctive Epicardial Vascular Physiologic Status Indicator870.220021
SDJAdjunctive Cardiac Amyloidosis Status Indicator870.220023
QAQAdjunctive Predictive Cardiovascular Indicator870.221025
QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator870.221025
QNVAdjunctive Hemodynamic Indicator With Decision Point870.222023
SARAdjunctive Hemodynamic Indicator With Decision Point For Military Use870.222021
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)870.23002338
MSXSystem, Network And Communication, Physiological Monitors870.23002116
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)870.23002304
PFYLow Patient Acuity Monitoring System870.230020
PLBMultivariate Vital Signs Index870.230028
DQHCardiograph, Apex (Vibrocardiograph)870.231021
DXRBallistocardiograph870.232025
DXKEchocardiograph870.2330278
DPSElectrocardiograph870.23402575
MLCMonitor, St Segment870.234022
QDAElectrocardiograph Software For Over-The-Counter Use870.234529
DRWAdaptor, Lead Switching, Electrocardiograph870.235028
DRXElectrode, Electrocardiograph870.23602329
MLNElectrode, Electrocardiograph, Multi-Function870.236020
KRCTester, Electrode, Surface, Electrocardiographic870.2370211
QXOCardiovascular Machine Learning-Based Notification Software870.238021
QXXCoronary Artery Disease Machine Learning-Based Notification Software870.238021
QYEReduced Ejection Fraction Machine Learning-Based Notification Software870.238025
SATPulmonary Hypertension Machine Learning-Based Notification Software870.238022
SBQAtrial Fibrillation Risk Prediction Machine Learning-Based Notification Software870.238021
SFRHypertension Machine Learning-Based Notification Software870.238021
SHPCardiac Amyloidosis Machine Learning-Based Notification Software870.238021
DQCPhonocardiograph870.2390118
DYCVectorcardiograph870.240024
DXJDisplay, Cathode-Ray Tube, Medical870.2450278
DRJSystem, Signal Isolation870.260014
DRIMonitor, Line Isolation870.262014
DSMAlarm, Leakage Current, Portable870.264011
DRZOscillometer870.267520
DQAOximeter870.27002723
MUDOximeter, Tissue Saturation870.2700273
NLFOximeter, Reprocessed870.2700227
NMDOximeter, Tissue Saturation, Reprocessed870.270022
OCHOximeter, Infrared, Sporting, Aviation870.270020
OLKPulse Oximeter For Over-The-Counter Use870.270022
PGJOximeter, Wellness870.270020
QEMCerebral Oximeter870.270021
QYUInfant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use870.270522
DPZOximeter, Ear870.2710211
DQBPhlebograph, Impedance870.275023
OFMPhlebotomy Blood Collection Kit870.275020
DSBPlethysmograph, Impedance870.27702114
MNWAnalyzer, Body Composition870.2770279
OACPlethysmograph, Air Displacement For Body Composition Analysis870.277023
OBHMonitor, Extracellular Fluid, Lymphedema, Extremity870.2770210
OMVUltrasonic Body Composition Analyzer870.277021
PUHAnalyzer, Body Composition, Exempt870.277020
QAFImpedance Plethysmograph, Cranial870.277022
QJBAdjunct Monitor, Protein Calorie Malnutrition870.277022
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic870.2780253
QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate870.2785210
QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate870.278621
QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use870.279025
SDYLoss Of Pulse Notification Software870.279021
DSHRecorder, Magnetic Tape, Medical870.28002193
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm870.2800232
MWJElectrocardiograph, Ambulatory (Without Analysis)870.2800259
MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)870.2800223
DSFRecorder, Paper Chart870.2810187
JONTransducer, Apex Cardiographic870.284020
DRSTransducer, Blood-Pressure, Extravascular870.28502148
NQHSensor, Pressure, Aneurysm, Implantable870.285525
JOOTransducer, Heart Sound870.286020
DXOTransducer, Pressure, Catheter Tip870.2870264
JOPTransducer, Ultrasonic870.2880272
DXPTransducer, Vessel Occlusion870.289022
DSACable, Transducer And Electrode, Patient, (Including Connector)870.29002105
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency870.29102191
DXHTransmitters And Receivers, Electrocardiograph, Telephone870.29202297
DSSClip, Vascular870.325028
DSTClip, Vena-Cava870.326021
KRDDevice, Vascular, For Promoting Embolization870.33002129
NAJAgents, Embolic, For Treatment Of Uterine Fibroids870.330028
QZUTemporary Embolization Assist Device, Peripheral870.332521
DTKFilter, Intravascular, Cardiovascular870.3375284
PNSShort-Term Intravascular Filter Catheter870.337521
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter870.34502188
DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter870.3450221
MABMarker, Cardiopulmonary Bypass (Vein Marker)870.345023
MALGraft, Vascular, Synthetic/Biologic Composite870.345028
MZYGraft, Vascular, Stainless Steel Tunneler870.345020
OTDEndovascular Suturing System870.346027
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene870.3470290
MFXVessel Guard Or Cover, To Facilitate Revision Surgeries870.347022
OMHPericardial Patch To Facilitate Revision Surgeries870.347021
OMRVessel Guard Or Cover870.3470210
PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement870.347023
PSQIntracardiac Patch Or Pledget, Biologically Derived870.3470211
SBKArtificial Chordae Tendineae Surgical Replacement System870.349021
DSPSystem, Balloon, Intra-Aortic And Control870.35352162
NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed870.353530
OKRVentricular Bypass (Assist) Device870.354530
PCKPediatric Ventricular Assist Device870.3545f0
DTEPulse-Generator, Pacemaker, External870.3600265
OVJPulse Generator, External Pacemaker, Dual Chamber870.360020
QABPacing System Analyzer870.360520
DSZPacemaker Battery870.361030
DXYImplantable Pacemaker Pulse-Generator870.36103471
PNJLeadless Pacemaker870.361032
DTDPacemaker Lead Adaptor870.36202103
DTCAnalyzer, Pacemaker Generator Function870.3630230
KREAnalyzer, Pacemaker Generator Function, Indirect870.3640213
DSWBag, Polymeric Mesh, Pacemaker870.365010
KRFCharger, Pacemaker870.367010
DTBPermanent Pacemaker Electrode870.36803490
LDFElectrode, Pacemaker, Temporary870.36802128
NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial870.368022
DTGMagnet, Test, Pacemaker870.369015
KRGProgrammer, Pacemaker870.3700325
KFJMaterials, Repair Or Replacement, Pacemaker870.371033
DTATester, Pacemaker Electrode Function870.3720210
DTFTools, Pacemaker Service870.373012
KRHRing, Annuloplasty870.3800274
PSTAortic Annuloplasty Ring870.380022
DSRStimulator, Carotid Sinus Nerve870.385031
DYEReplacement Heart-Valve870.392538
PALPulmonic Replacement Heart Valve870.3925f0
DTJHolder, Heart-Valve, Prosthesis870.3935112
MOPRotator, Prosthetic Heart Valve870.393514
DTISizer, Heart-Valve, Prosthesis870.394517
QWACardiovascular Delivery Catheter System Positioning And Stabilization Device870.395510
DWZDevice, Biopsy, Endomyocardial870.4075223
MFYEndothelial Cell Harvesting Kit870.407521
OFGCt Biopsy Tray870.407520
BYSOxygenator, Long Term Support Greater Than 6 Hours870.410023
PZSDual Lumen Ecmo Cannula870.410024
QHWSingle Lumen Ecmo Cannula870.410023
QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure870.410023
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use870.410028
QWFTubing, Long Term Support Greater Than 6 Hours870.410021
QOHExtracorporeal System For Carbon Dioxide Removal870.415021
KRIAccessory Equipment, Cardiopulmonary Bypass870.4200142
KRLDetector, Bubble, Cardiopulmonary Bypass870.4205214
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass870.42102400
OEUCardiopulmonary Bypass Catheter Kit870.421020
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass870.4220252
DTPDefoamer, Cardiopulmonary Bypass870.4230234
DTRHeat-Exchanger, Cardiopulmonary Bypass870.4240291
OETCardioplegia Solution Administration Kit870.424020
DWCController, Temperature, Cardiopulmonary Bypass870.4250230
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line870.4260296
JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass870.4270212
KRJFilter, Prebypass, Cardiopulmonary Bypass870.4280224
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass870.42902137
DTXGas Control Unit, Cardiopulmonary Bypass870.4300210
DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass870.4310213
JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass870.432030
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass870.4330247
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass870.4340217
DTZOxygenator, Cardiopulmonary Bypass870.43502254
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type870.4360284
PYXTemporary Non-Roller Type Right Heart Support Blood Pump870.436031
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type870.4370221
DWAControl, Pump Speed, Cardiopulmonary Bypass870.4380237
DWETubing, Pump, Cardiopulmonary Bypass870.4390221
DTNReservoir, Blood, Cardiopulmonary Bypass870.44002169
MJJCpb Check Valve, Retrograde Flow, In-Line870.440029
MNJValve, Pressure Relief, Cardiopulmonary Bypass870.440022
PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt870.440020
DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass870.441028
DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass870.442029
DWDSuction Control, Intracardiac, Cardiopulmonary Bypass870.4430215
DXCClamp, Vascular870.44502202
MJNCatheter, Intravascular Occluding, Temporary870.4450290
NMFClamp, Vascular, Reprocessed870.445023
DWPDilator, Vessel, Surgical870.4475220
DWSInstruments, Surgical, Cardiovascular870.4500171
LXNProbe, Test, Heart-Valve870.450012
MWSStabilizer, Heart870.450014
NQGStabilizer, Heart, Non-Compression, Reprocessed870.450013
OFACardiovascular Surgical Instruments Tray870.450010
PNQApical Closure Device870.451021
QVQExtravascular Support For An Arteriovenous Fistula For Vascular Access870.460022
DWXStripper, Artery, Intraluminal870.4875214
MCWCatheter, Peripheral, Atherectomy870.48752146
QTFReprocessed Atherectomy Catheter870.487521
DWQStripper, Vein, External870.488528
MGZValvulotome870.4885227
NLJStripper, Vein, External, Reprocessed870.488520
DWMApparatus, Suction, Patient Care870.5050219
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous870.51002106
SEUPeripheral Temporary And Retrievable Stent System870.511021
QRJLaser-Powered Inferior Vena Cava Filter Retrieval Catheter870.512521
DXECatheter, Embolectomy870.5150274
MMXDevice, Percutaneous Retrieval870.5150232
QEWPeripheral Mechanical Thrombectomy With Aspiration870.51502140
QEXCoronary Mechanical Thrombectomy With Aspiration870.515023
QEYMechanical Thrombolysis Catheter870.5150271
QEZAspiration Thrombectomy Catheter870.5150291
DXFCatheter, Septostomy870.5175220
QLZSeptostomy Catheter, Reprocessed870.517522
DRMCompressor, Cardiac, External870.5200245
LIXAid, Cardiopulmonary Resuscitation870.5210217
PMJCpr Aid Feedback Device (No Software)870.521020
PMKCpr Aid Device Without Feedback870.521012
DRNDevice, Counter-Pulsating, External870.5225234
DRKDc-Defibrillator, High Energy, (Including Paddles)870.530031
LDDDc-Defibrillator, Low-Energy, (Including Paddles)870.53002166
MPCAtrial Defibrillator870.530030
MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator870.530023
MKJAutomated External Defibrillators (Non-Wearable)870.53103245
NSAOver-The-Counter Automated External Defibrillator870.531032
DRLTester, Defibrillator870.5325219
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)870.5550284
MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker870.555021
QMSAdjunctive Open Loop Fluid Therapy Recommender870.560022
PJBCatheter Remote Control System870.570024
QXUEsophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation870.571022
QXVTemperature Regulation Device For Esophageal Protection During Cardiac Ablation870.572021
JOWSleeve, Limb, Compressible870.58002349
LHXTrousers, Anti-Shock870.580024
PPSSleeve, Head And Neck, Compressible870.580021
DWJSystem, Thermal Regulating870.59002158
NCXSystem, Hypothermia, Intravenous, Cooling870.5900226
NZEHyperthermia Monitor870.590026
PLAEsophageal Thermal Regulation And Gastric Suctioning Device870.591029
DRPTourniquet, Automatic Rotating870.592520
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices892.2050210
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