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
14852 Cardiovascular devices
6051–6075 of 14852
Cleared Oct 15, 2008
PRELUDE SHORT SHEATH INTRODUCER
K082063 · Merit Medical Systems, Inc.
DYB · Introducer, Catheter · 86d
Cleared Oct 15, 2008
FLOWPICC CONSOLE
K081626 · Vasonova, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 127d
Cleared Oct 14, 2008
PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER
K081793 · Philips Medizin Systeme Boeblingen GmbH
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 111d
Cleared Oct 10, 2008
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
K082959 · Unimed Medical Supplies, Inc.
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 7d
Cleared Oct 10, 2008
TEMPUSIC PATIENT MONITOR
K082718 · Remote Diagnostic Technologies , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 23d
Cleared Oct 10, 2008
HEM-9000AI
K081654 · Omron Healthcare, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 120d
Cleared Oct 08, 2008
SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR
K082280 · Philips Medical Systems North America Co.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 58d
Cleared Oct 08, 2008
ICON, MODEL C3
K082242 · Osypka Medical, Inc.
DSB · Plethysmograph, Impedance · 62d
Cleared Oct 08, 2008
BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001
K081187 · Bridgepoint Medical
DQX · Wire, Guide, Catheter · 163d
Cleared Oct 06, 2008
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
K082664 · Pathway Medical Technologies, Inc.
MCW · Catheter, Peripheral, Atherectomy · 24d
Cleared Oct 06, 2008
LYMPHA PRESS OPTIMAL, MODEL# 1201AP
K082149 · Mego Afek AC , Ltd.
JOW · Sleeve, Limb, Compressible · 68d
Cleared Oct 06, 2008
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
K081820 · Avalon Laboratories, LLC
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 101d
Cleared Oct 03, 2008
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
K082633 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
DSI · Detector And Alarm, Arrhythmia · 23d
Cleared Oct 03, 2008
QUART ARTERIAL FILTER WITH BIOLINE COATING
K082544 · Maquet Cardiopulmonary, AG
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 30d
Cleared Oct 03, 2008
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
K081933 · Avalon Laboratories, LLC
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 88d
Cleared Oct 03, 2008
GORE TRI-LOBE BALLOON CATHETER
K081799 · W.L. Gore & Associates, Inc.
DQY · Catheter, Percutaneous · 100d
Cleared Oct 02, 2008
LBI EMBOLECTOMY SYSTEM
K080901 · Lumen Biomedical, Inc.
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 185d
Cleared Oct 02, 2008
6F PROXIS SYSTEM
K073700 · St. Jude Medical, Inc.
DQY · Catheter, Percutaneous · 276d
Cleared Sep 26, 2008
GALAXY 55
K082685 · Larsen & Toubro Limited
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 11d
Cleared Sep 26, 2008
MINI GHOST, MODEL: 507
K082524 · NuMED, Inc.
DQY · Catheter, Percutaneous · 24d
Cleared Sep 26, 2008
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · Terumo Medical Corp.
KRA · Catheter, Continuous Flush · 24d
Cleared Sep 26, 2008
LIFEBED PATIENT VIGILANCE SYSTEM
K082366 · Hoana Medical, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 39d
Cleared Sep 26, 2008
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
K082256 · Integrated Medical Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 49d
Cleared Sep 26, 2008
MODIFICATION TO FETCH ASPIRATION CATHETER
K081989 · Possis Medical, Inc.
QEZ · Aspiration Thrombectomy Catheter · 74d
Cleared Sep 26, 2008
ACUNAV V ULTRASOUND CATHETER
K081808 · Siemens Medical Solutions USA, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 92d

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All categories 14852 DXN System, Measurement, Blood-pressure, Non-invasive 930 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) 409 DQO Catheter, Intravascular, Diagnostic 400 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 279 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 272