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
14865 Cardiovascular devices
6251–6275 of 14865
Cleared Mar 20, 2008
CLARIVEIN CATHETER
K071468 · Vascular Insights, LLC
KRA · Catheter, Continuous Flush · 296d
Cleared Mar 19, 2008
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K072527 · Zoll Circulation
DRM · Compressor, Cardiac, External · 194d
Cleared Mar 13, 2008
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
K080500 · Acumen Medical, Inc.
DYB · Introducer, Catheter · 17d
Cleared Mar 13, 2008
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
K080461 · Philips Medical Systems
MLD · Monitor, St Segment With Alarm · 22d
Cleared Mar 13, 2008
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · Medtronic, Inc.
KRH · Ring, Annuloplasty · 107d
Cleared Mar 13, 2008
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
K073260 · Device Partners International
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 114d
Cleared Mar 13, 2008
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
K072864 · St. Jude Medical, Cardiac Rhythm Management Divisi
DRB · Stylet, Catheter · 160d
Cleared Mar 11, 2008
ATRICURE COOLRAIL LINEAR PEN
K073605 · AtriCure, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 81d
Cleared Mar 07, 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · Terumo Medical Corp.
DYB · Introducer, Catheter · 22d
Cleared Mar 07, 2008
COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
K073374 · William Cook Europe Aps
DTK · Filter, Intravascular, Cardiovascular · 95d
Cleared Mar 07, 2008
VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30
K073028 · Venowave, Inc.
JOW · Sleeve, Limb, Compressible · 133d
Cleared Mar 07, 2008
CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp
DYB · Introducer, Catheter · 164d
Cleared Mar 07, 2008
AMADEUS ADAPTIVE COMPRESSION THERAPY
K071763 · Convatec
JOW · Sleeve, Limb, Compressible · 252d
Cleared Mar 05, 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
K073544 · Rj Medical, Inc.
KRD · Device, Vascular, For Promoting Embolization · 78d
Cleared Mar 05, 2008
CAPIOX CIRCUIT CONNECTORS
K073474 · Terumo Corp.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 85d
Cleared Mar 05, 2008
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc.
DXQ · Blood Pressure Cuff · 307d
Cleared Mar 04, 2008
FLEXOR EVAC ASPIRATION CATHETER
K073627 · Cook, Inc.
QEZ · Aspiration Thrombectomy Catheter · 69d
Cleared Feb 29, 2008
HEART SYNC, MODELS C-100 AND T-100
K080421 · Heart Sync, LLC
MKJ · Automated External Defibrillators (non-wearable) · 14d
Cleared Feb 29, 2008
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI
K073380 · Sorin Group Italia S.R.L.
DTZ · Oxygenator, Cardiopulmonary Bypass · 88d
Cleared Feb 28, 2008
PACIFICA
K073407 · Or-Nim Medical , Ltd.
MUD · Oximeter, Tissue Saturation · 86d
Cleared Feb 27, 2008
GUARDIAN HEMOSTASIS VALVE
K073620 · Zerusa Limited
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 63d
Cleared Feb 27, 2008
VENA CAVA FILTER
K073528 · Cook Incorporated
DTK · Filter, Intravascular, Cardiovascular · 72d
Cleared Feb 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
K080342 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 18d
Cleared Feb 26, 2008
1500 PRO
K080289 · Omron Healthcare, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 22d
Cleared Feb 26, 2008
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · Radi Medical Systems AB
DXC · Clamp, Vascular · 29d

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

Search all Cardiovascular 510(k) devices

Filter by Product Code

All categories 14865 DXN System, Measurement, Blood-pressure, Non-invasive 931 DQY Catheter, Percutaneous 788 DQX Wire, Guide, Catheter 699 DYB Introducer, Catheter 633 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