FDA Review Panel · CV

FDA 510(k) Cardiovascular Devices

FDA 510(k) Cardiovascular Devices - Regulatory Overview

FDA 510(k) cardiovascular devices represent one of the largest device categories, with 17,947 submissions since 1976. The FDA review panel code is CV.

This category covers a wide risk spectrum:

Class I / II - blood pressure monitors, stethoscopes, ECG systems, holter monitors
Class II Special Controls - catheters, guidewires, cardiac ablation systems
Class II / III - pacemakers, implantable defibrillators, stents

Top product codes include DXN (blood pressure systems, 1,201 devices) and DQY (percutaneous catheters, 850 devices). Average FDA review time: 125 days.

18151

Total

18097

Cleared

152d

Avg (2y)

1976

Since

15150 Cardiovascular devices

12001–12025 of 15150

Cleared Jul 28, 1988

MEDRAD OPEN ENDED GUIDEWIRE

K880332 · Medrad, Inc.

DQX · Wire, Guide, Catheter · 184d

Cleared Jul 28, 1988

CORDIS PTA DILATATION CATHETERS

K880612 · Cordis Corp.

LIT · Catheter, Angioplasty, Peripheral, Transluminal · 163d

Cleared Jul 28, 1988

MODEL BPS08 BLOOD PRESSURE MODULE

K881155 · Fresenius USA, Inc.

DXN · System, Measurement, Blood-pressure, Non-invasive · 132d

Cleared Jul 28, 1988

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER

K881968 · Biodynamics Corp.

DSB · Plethysmograph, Impedance · 78d

Cleared Jul 28, 1988

VITALERT 2000 VITAL SIGNS MONITOR

K882031 · Draeger Medical, Inc.

DXO · Transducer, Pressure, Catheter Tip · 73d

Cleared Jul 28, 1988

INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER

K882034 · Buckman Co., Inc.

DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 73d

Cleared Jul 28, 1988

HEART-CHILL SALINE SLUSH PAD

K882035 · Buckman Co., Inc.

DWJ · System, Thermal Regulating · 73d

Cleared Jul 28, 1988

CARDIOCAP(TM) CMO-104 MONITOR

K882093 · Datex Division Instrumentarium Corp.

DSK · Computer, Blood-pressure · 70d

Cleared Jul 28, 1988

TUNNELING STYLET

K882097 · Quinton, Inc.

DRB · Stylet, Catheter · 70d

Cleared Jul 28, 1988

MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR

K882188 · Ivy Biomedical Systems, Inc.

DXN · System, Measurement, Blood-pressure, Non-invasive · 65d

Cleared Jul 28, 1988

MINIMON 7132B PATIENT MONITOR

K882198 · Kontron Instruments, Inc.

DPS · Electrocardiograph · 64d

Cleared Jul 28, 1988

SLIP-COAT(TM) CATHETERS

K882796 · Cook, Inc.

DQO · Catheter, Intravascular, Diagnostic · 22d

Cleared Jul 27, 1988

LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR

K881153 · Physio-Control Corp.

LDD · Dc-defibrillator, Low-energy, (including Paddles) · 132d

Cleared Jul 26, 1988

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE

K881796 · Universal Medical Instrument Corp.

DWS · Instruments, Surgical, Cardiovascular · 90d

Cleared Jul 25, 1988

ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE

K881787 · Advanced Cardiovascular Systems, Inc.

DQX · Wire, Guide, Catheter · 90d

Cleared Jul 22, 1988

CARD GUARD, MODEL CG-2000

K882290 · Card Guard Scientific Survival , Ltd.

DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 51d

Cleared Jul 20, 1988

SYNCOR (R) MODEL S-801 ECG ELECTRODE

K882216 · Lectec Corp.

DRX · Electrode, Electrocardiograph · 55d

Cleared Jul 18, 1988

K880936 · Cardiotronics, Inc.

DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 133d

Cleared Jul 18, 1988

OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

K881837 · Telectronics, Inc.

DXY · Implantable Pacemaker Pulse-generator · 77d

Cleared Jul 14, 1988

BUBBLE TRAP-FILTER CAT. NO B180F37

K873316 · American Omni Medical, Inc.

DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 330d

Cleared Jul 14, 1988

WS 800R THERMAL ARRAY RECORDER

K881831 · Nihon Kohden America, Inc.

DSF · Recorder, Paper Chart · 76d

Cleared Jul 12, 1988

HORIZON 2000 ARRHYTHMIA MONITORING OPTION

K881273 · Mennen Medical, Inc.

DSI · Detector And Alarm, Arrhythmia · 109d

Cleared Jul 12, 1988

ESCORT - PORTABLE PATIENT MONITOR

K881986 · Medical Data Electronics

DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 61d

Cleared Jul 12, 1988

MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR

K882513 · Cardiac Resucitator Corp.

DSI · Detector And Alarm, Arrhythmia · 40d

Cleared Jul 06, 1988

SHILEY FEMORAL CORONARY PERFUSION CATHETER

K881733 · Shiley, Inc.

DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 75d

Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.

Search all Cardiovascular 510(k) devices