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
14956 Cardiovascular devices
7826–7850 of 14956
Cleared May 02, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030026 · Alliance Medical Corp.
NLH · Catheter, Recording, Electrode, Reprocessed · 119d
Cleared May 02, 2003
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
K031223 · Dideco S.P.A.
DTZ · Oxygenator, Cardiopulmonary Bypass · 14d
Cleared Apr 24, 2003
ELOX P 45-BP
K023205 · Biotronik, Inc.
DTB · Permanent Pacemaker Electrode · 211d
Cleared Apr 24, 2003
HL888JF
K030541 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 63d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779 · Medtronic Vascular
DQY · Catheter, Percutaneous · 44d
Cleared Apr 24, 2003
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT
K030984 · Intra Luminal Therapeutics, Inc.
DQY · Catheter, Percutaneous · 27d
Cleared Apr 24, 2003
EDWARDS INTRODUCER SHEATH
K031087 · Edwards Lifesciences, LLC
DYB · Introducer, Catheter · 17d
Cleared Apr 22, 2003
STEELEX ELECTRODE SET
K030556 · Aesculap, Inc.
LDF · Electrode, Pacemaker, Temporary · 60d
Cleared Apr 18, 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
K030231 · Sorin Group Italia S.R.L.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 86d
Cleared Apr 17, 2003
HL888HM
K030499 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 57d
Cleared Apr 17, 2003
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
K030613 · Criticare Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 50d
Cleared Apr 11, 2003
HL888HA
K030498 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 51d
Cleared Apr 11, 2003
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)
K030696 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 36d
Cleared Apr 09, 2003
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K030905 · Medamicus, Inc.
DYB · Introducer, Catheter · 16d
Cleared Apr 09, 2003
EPTFE VASCULAR PROSTHESIS
K030999 · Vascutek, Ltd.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 9d
Cleared Apr 08, 2003
STEREOTAXIS CATHETER ADVANCER SYSTEM
K021802 · Stereotaxis, Inc.
DQY · Catheter, Percutaneous · 309d
Cleared Mar 31, 2003
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
K023381 · Gish Biomedical, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 174d
Cleared Mar 31, 2003
GISH ARTERIAL FILTER WITH GBS COATING
K023833 · Gish Biomedical, Inc.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 133d
Cleared Mar 31, 2003
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K030154 · Dideco S.P.A.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 74d
Cleared Mar 28, 2003
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · Micro Therapeutics, Inc.
KRA · Catheter, Continuous Flush · 23d
Cleared Mar 26, 2003
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201 · Medtronic Vascular
NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection · 64d
Cleared Mar 21, 2003
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K030114 · Vanguard Medical Concepts, Inc.
NLH · Catheter, Recording, Electrode, Reprocessed · 67d
Cleared Mar 21, 2003
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
K030575 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 25d
Cleared Mar 21, 2003
INFINITY EXPLORER
K030615 · Siemens Medical Solutions USA, Inc.
MSX · System, Network And Communication, Physiological Monitors · 23d
Cleared Mar 21, 2003
M2376A DEVICELINK SYSTEM
K030731 · Philips Medical Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 11d

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All categories 14956 DXN System, Measurement, Blood-pressure, Non-invasive 939 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 638 DPS Electrocardiograph 443 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 402 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 365 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 337 DSI Detector And Alarm, Arrhythmia 309 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275