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.

18110
Total
18057
Cleared
149d
Avg (2y)
1976
Since
14861 Cardiovascular devices
6126–6150 of 14861
Cleared Aug 15, 2008
TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX
K080189 · Trimline Medical Products Corp.
DXQ · Blood Pressure Cuff · 203d
Cleared Aug 14, 2008
MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K081944 · Cardio Systems, Inc.
MCW · Catheter, Peripheral, Atherectomy · 37d
Cleared Aug 12, 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
K080637 · Stereotaxis, Inc.
DQX · Wire, Guide, Catheter · 159d
Cleared Aug 11, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K082059 · Angioscore, Inc.
PNO · Catheter, Percutaneous, Cutting/scoring · 21d
Cleared Aug 11, 2008
FINDRWIRZ GUIDE WIRE SYSTEM
K080364 · Sentreheart, Inc.
DQX · Wire, Guide, Catheter · 182d
Cleared Aug 08, 2008
APPROACH CTO WIRE GUIDE
K081337 · Cook Incorporated
DQX · Wire, Guide, Catheter · 87d
Cleared Aug 08, 2008
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
K081159 · Harvard Medical Devices , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 116d
Cleared Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · Boston Scientific Corp
DQX · Wire, Guide, Catheter · 120d
Cleared Aug 08, 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · Cook, Inc.
KRA · Catheter, Continuous Flush · 144d
Cleared Aug 05, 2008
PIONEER PLUS CATHETER
K081804 · Medtronic, Inc.
PDU · Catheter For Crossing Total Occlusions · 40d
Cleared Aug 01, 2008
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K082045 · Spacelabs Medical, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 14d
Cleared Aug 01, 2008
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523 · Medtronic, Inc.
NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection · 231d
Cleared Jul 31, 2008
SKYLINE 55
K081552 · Larsen & Toubro Limited
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 58d
Cleared Jul 31, 2008
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
K081444 · Braemar, Inc.
DSI · Detector And Alarm, Arrhythmia · 70d
Cleared Jul 31, 2008
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080326 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 176d
Cleared Jul 31, 2008
STATMAP, MODEL 7200
K072109 · Ramsey Medical, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 365d
Cleared Jul 30, 2008
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
K080832 · Sorin Group Deutschland GmbH
DTQ · Console, Heart-lung Machine, Cardiopulmonary Bypass · 127d
Cleared Jul 30, 2008
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
K080668 · C.R. Bard, Inc.
DTK · Filter, Intravascular, Cardiovascular · 142d
Cleared Jul 29, 2008
LIFEPAK 20E
K073089 · Physio-Control, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 271d
Cleared Jul 28, 2008
T-STAT 303 ISCHEMIA MONITORING SYSTEM
K081233 · Spectros Corporation
MUD · Oximeter, Tissue Saturation · 88d
Cleared Jul 28, 2008
VALVULOTOME BY KOVEN
K080178 · Koven Technology, Inc.
MGZ · Valvulotome · 186d
Cleared Jul 25, 2008
MICROSHEATH LP AND LP-AT
K080849 · Flowcardia, Inc.
DQY · Catheter, Percutaneous · 121d
Cleared Jul 25, 2008
EPICOR ABLATION SYSTEM
K080292 · St Jude Medical
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 172d
Cleared Jul 22, 2008
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
K081776 · Omega Critical Care Limited
DXG · Computer, Diagnostic, Pre-programmed, Single-function · 29d
Cleared Jul 18, 2008
MODIFIED HD GUIDE CATHETER
K080583 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 137d

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All categories 14861 DXN System, Measurement, Blood-pressure, Non-invasive 931 DQY Catheter, Percutaneous 788 DQX Wire, Guide, Catheter 699 DYB Introducer, Catheter 632 DPS Electrocardiograph 438 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 410 DQO Catheter, Intravascular, Diagnostic 401 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 376 LIT Catheter, Angioplasty, Peripheral, Transluminal 362 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 280 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 273