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
14985 Cardiovascular devices
8451–8475 of 14985
Cleared Jul 13, 2000
WELCH ALLYN INSTRUMENT INTERFACE MODULE
K001265 · Welch Allyn, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 85d
Cleared Jul 12, 2000
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · NuMED, Inc.
DXF · Catheter, Septostomy · 27d
Cleared Jul 12, 2000
AMPLATZER SIZING BALLOON
K993248 · Aga Medical Corp.
MJN · Catheter, Intravascular Occluding, Temporary · 288d
Cleared Jul 07, 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · Cordis Corp.
DTK · Filter, Intravascular, Cardiovascular · 179d
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K001063 · Baxter Healthcare Corp
DYG · Catheter, Flow Directed · 95d
Cleared Jul 07, 2000
SNIPER, MODEL OR-3872XX SERIES
K001251 · Nipro Medical Corp.
DQX · Wire, Guide, Catheter · 79d
Cleared Jul 07, 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032 · Bridger Biomed, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 224d
Cleared Jul 03, 2000
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · Cordis Corp.
DYB · Introducer, Catheter · 84d
Cleared Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
K001848 · Omron Healthcare, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 14d
Cleared Jun 30, 2000
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
K001081 · Cardiodynamics International Corp.
DSB · Plethysmograph, Impedance · 87d
Cleared Jun 30, 2000
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
K001664 · Agilent Technologies, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 30d
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · Omron Healthcare, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 29d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · Omron Healthcare, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 29d
Cleared Jun 30, 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K001776 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 30d
Cleared Jun 27, 2000
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
K001180 · Pace Medical
DTE · Pulse-generator, Pacemaker, External · 77d
Cleared Jun 27, 2000
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
K001305 · General Electric Medical Systems Information Techn
DQK · Computer, Diagnostic, Programmable · 64d
Cleared Jun 23, 2000
GEMINI E
K993623 · Allen Medical Instruments Corp.
DQD · Stethoscope, Electronic · 241d
Cleared Jun 22, 2000
VASO PRESS DVT SYSTEM, MODELS VP500, VP501
K991038 · Britt Corp., Inc.
JOW · Sleeve, Limb, Compressible · 451d
Cleared Jun 16, 2000
TEARAWAY INTRODUCER SHEATH
K000313 · Xentek Medical, Inc.
DYB · Introducer, Catheter · 136d
Cleared Jun 16, 2000
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular
DRB · Stylet, Catheter · 84d
Cleared Jun 16, 2000
ECHOCOM, IMAGECOM, DOKUCOM
K001592 · Tomtec Imaging Systems GmbH
DQK · Computer, Diagnostic, Programmable · 24d
Cleared Jun 14, 2000
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
K001112 · General Electric Medical Systems Information Techn
DXJ · Display, Cathode-ray Tube, Medical · 69d
Cleared Jun 14, 2000
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · Cobe Cardiovascular, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 183d
Cleared Jun 13, 2000
EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
K000237 · Cybercare, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 138d
Cleared Jun 09, 2000
MODEL APS ALTERNANS PROCESSING SYSTEM
K001034 · Cambridge Heart, Inc.
DPS · Electrocardiograph · 70d

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All categories 14985 DXN System, Measurement, Blood-pressure, Non-invasive 942 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 702 DYB Introducer, Catheter 638 DPS Electrocardiograph 444 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 366 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 339 DSI Detector And Alarm, Arrhythmia 310 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275