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
15029 Cardiovascular devices
9551–9575 of 15029
Cleared Apr 10, 1997
CARDIO TEAM II
K962937 · Vision Electronics
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 255d
Cleared Apr 09, 1997
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
K962700 · Vasamedics, LLC
DPT · Probe, Blood-flow, Extravascular · 271d
Cleared Apr 09, 1997
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
K970796 · 3M Healthcare
DRX · Electrode, Electrocardiograph · 36d
Cleared Apr 04, 1997
FLEXIBLE DILATING SHEATH
K945586 · Med Institute, Inc.
DRE · Dilator, Vessel, For Percutaneous Catheterization · 872d
Cleared Apr 04, 1997
HEARTPORT ENDOAORTIC CLAMP
K964161 · Heartport, Inc.
DXC · Clamp, Vascular · 169d
Cleared Apr 03, 1997
CTS MIDCAB CORONARY SHUNT
K963503 · Cardiothoracic Systems, Inc.
DXC · Clamp, Vascular · 212d
Cleared Apr 02, 1997
SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
K952912 · Spacelabs Medical, Inc.
DSI · Detector And Alarm, Arrhythmia · 646d
Cleared Apr 02, 1997
MICS DEVICE SYSTEM
K963716 · Percutaneous Technologies, Inc.
DXC · Clamp, Vascular · 198d
Cleared Apr 01, 1997
CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER
K954547 · Citizen Watch Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 550d
Not Cleared Apr 01, 1997
OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
K964107 · Oscor Medical Corp.
DTB · Permanent Pacemaker Electrode · 168d
Cleared Apr 01, 1997
D SERIES ELECTRODE
K970603 · Cmc Sense-It, Inc.
DSB · Plethysmograph, Impedance · 42d
Cleared Mar 28, 1997
AIRCAST VENAFLOW SYSTEM (MODIFICATION)
K961676 · Aircast, Inc.
JOW · Sleeve, Limb, Compressible · 350d
Cleared Mar 28, 1997
FOCUS PV BALLOON DILATATION CATHETER
K963688 · Cardiovascular Dynamics, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 193d
Cleared Mar 28, 1997
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
K965214 · Coeur Laboratories, Inc.
DTX · Gas Control Unit, Cardiopulmonary Bypass · 88d
Cleared Mar 28, 1997
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
K970244 · Scimed Life Systems, Inc.
DQX · Wire, Guide, Catheter · 65d
Cleared Mar 28, 1997
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources
DXE · Catheter, Embolectomy · 25d
Cleared Mar 26, 1997
MAGNO ALARM
K960849 · Cardiac Assist Devices, Inc.
DTG · Magnet, Test, Pacemaker · 400d
Cleared Mar 25, 1997
SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
K962970 · Spacelabs Medical, Inc.
DSI · Detector And Alarm, Arrhythmia · 237d
Cleared Mar 24, 1997
SPINNAKER
K965189 · Target Therapeutics
KRA · Catheter, Continuous Flush · 90d
Cleared Mar 21, 1997
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
K963057 · Fukuda Denshi USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 227d
Cleared Mar 21, 1997
CES INFUSION CATHETER
K965181 · Cordis Neurovascular, Inc.
KRA · Catheter, Continuous Flush · 87d
Cleared Mar 20, 1997
CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
K963698 · International Biophysics Corp.
DTY · Sensor, Blood-gas, In-line, Cardiopulmonary Bypass · 185d
Cleared Mar 20, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K964877 · Impra, Inc.
DYF · Prosthesis, Vascular Graft, Of Less Then 6mm Diameter · 105d
Cleared Mar 19, 1997
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766 · Meadox Medicals, Div. Boston Scientific Corp.
DYF · Prosthesis, Vascular Graft, Of Less Then 6mm Diameter · 387d
Cleared Mar 19, 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc.
DXT · Injector And Syringe, Angiographic · 289d

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All categories 15029 DXN System, Measurement, Blood-pressure, Non-invasive 944 DQY Catheter, Percutaneous 795 DQX Wire, Guide, Catheter 703 DYB Introducer, Catheter 638 DPS Electrocardiograph 445 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 415 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 381 LIT Catheter, Angioplasty, Peripheral, Transluminal 367 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 342 DSI Detector And Alarm, Arrhythmia 311 JOW Sleeve, Limb, Compressible 289 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275