Panels › Cardiovascular

Cardiovascular devices

304 product codes reviewed by the Cardiovascular panel. 19,244 510(k) clearances and 6,943 recalls in the FDA data, 81% of those recalls name a 510(k).

415510(k)s in 12 months

469recalls in 12 months

5,607recalls that name a 510(k)

Active product codes, Class II

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	2	15	36
OEZ	Cardiovascular Procedure Kit	2	0	50
DYB	Introducer, Catheter	2	19	27
KRA	Catheter, Continuous Flush	2	5	41
NLH	Catheter, Recording, Electrode, Reprocessed	2	1	32
OES	Cardiac Catheterization Kit	2	0	33
DQK	Computer, Diagnostic, Programmable	2	29	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	2	31	0
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	2	10	20
DQO	Catheter, Intravascular, Diagnostic	2	3	26
QJP	Catheter, Percutaneous, Neurovasculature	2	23	0
DQA	Oximeter	2	13	9
DSI	Detector And Alarm, Arrhythmia	2	1	20
DQX	Wire, Guide, Catheter	2	12	7
OEQ	Angiography/Angioplasty Kit	2	0	19
OFF	Central Venous Catheter Tray	2	0	19
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	2	6	11
NRY	Catheter, Thrombus Retriever	2	14	2
DQY	Catheter, Percutaneous	2	13	2
DXT	Injector And Syringe, Angiographic	2	7	8
MOF	Guide, Wire, Catheter, Neurovasculature	2	12	0
OFG	Ct Biopsy Tray	2	0	12
QEW	Peripheral Mechanical Thrombectomy With Aspiration	2	12	0
DPS	Electrocardiograph	2	7	4
DWJ	System, Thermal Regulating	2	6	3
JOW	Sleeve, Limb, Compressible	2	9	0
KRD	Device, Vascular, For Promoting Embolization	2	8	1
MSX	System, Network And Communication, Physiological Monitors	2	5	3
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	2	3	5
QEZ	Aspiration Thrombectomy Catheter	2	8	0
DQD	Stethoscope, Electronic	2	7	0
DSP	System, Balloon, Intra-Aortic And Control	2	0	7
LIT	Catheter, Angioplasty, Peripheral, Transluminal	2	5	2
DXC	Clamp, Vascular	2	6	0
DXQ	Blood Pressure Cuff	2	5	1
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	2	6	0
OWQ	Reprocessed Intravascular Ultrasound Catheter	2	1	5
DPW	Flowmeter, Blood, Cardiovascular	2	4	1
DRA	Catheter, Steerable	2	1	4
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	2	5	0
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	2	0	5
DTZ	Oxygenator, Cardiopulmonary Bypass	2	5	0
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	2	4	1
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	2	5	0
OBJ	Catheter, Ultrasound, Intravascular	2	4	1
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate	2	4	0
DRE	Dilator, Vessel, For Percutaneous Catheterization	2	2	1
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	2	2	1
DRS	Transducer, Blood-Pressure, Extravascular	2	1	2
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	2	3	0
DSH	Recorder, Magnetic Tape, Medical	2	3	0
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	2	1	2
DTR	Heat-Exchanger, Cardiopulmonary Bypass	2	1	2
DXF	Catheter, Septostomy	2	3	0
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	2	0	3
OFC	Catheter Introducer Kit	2	0	3
PNO	Catheter, Percutaneous, Cutting/Scoring	2	3	0
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	2	2	0
DSB	Plethysmograph, Impedance	2	2	0
DXE	Catheter, Embolectomy	2	0	2
DYG	Catheter, Flow Directed	2	0	2
IZQ	Injector, Contrast Medium, Automatic	2	2	0
KRH	Ring, Annuloplasty	2	2	0
LDF	Electrode, Pacemaker, Temporary	2	1	1
MGZ	Valvulotome	2	1	1
MTD	Catheter, Intracardiac Mapping, High-Density Array	2	2	0
MUD	Oximeter, Tissue Saturation	2	1	1
NTE	Temporary Carotid Catheter For Embolic Capture	2	0	2
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	2	2	0
OFB	Catheter Guide Wire Kit	2	0	2
OFK	Percutaneous Atrial Catheter Kit	2	0	2
OFL	Percutaneous Sheath Introducer Kit	2	0	2
OZT	Balloon Aortic Valvuloplasty	2	2	0
PNE	Reprocessed Catheter Introducer	2	2	0
PPN	Percutaneous Catheter, Ultrasound	2	2	0
PPW	Adjunctive Cardiovascular Status Indicator	2	2	0
QEY	Mechanical Thrombolysis Catheter	2	2	0
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	2	0	2
SAT	Pulmonary Hypertension Machine Learning-Based Notification Software	2	2	0
DRM	Compressor, Cardiac, External	2	0	1
DRN	Device, Counter-Pulsating, External	2	1	0
DTK	Filter, Intravascular, Cardiovascular	2	0	1
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	2	1	0
DTN	Reservoir, Blood, Cardiopulmonary Bypass	2	1	0
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	2	0	1
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	2	1	0
DXJ	Display, Cathode-Ray Tube, Medical	2	1	0
DXO	Transducer, Pressure, Catheter Tip	2	1	0
DXX	System, Catheter Control, Steerable	2	1	0
MAV	Syringe, Balloon Inflation	2	1	0
MCW	Catheter, Peripheral, Atherectomy	2	1	0
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	2	1	0
NMK	Trocar, Reprocessed	2	1	0
OFD	Catheter Introducer Kit	2	0	1
OFM	Phlebotomy Blood Collection Kit	2	0	1
PAW	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	2	1	0
PDU	Catheter For Crossing Total Occlusions	2	1	0
PJA	Coronary Vascular Physiologic Simulation Software	2	1	0
PTM	Syringe, Balloon Inflation, Exempt	2	0	1
PUM	Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	2	1	0

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