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
14952 Cardiovascular devices
7701–7725 of 14952
Cleared Nov 19, 2003
SPEEDLYSER INFUSION CATHETER KIT
K033443 · AngioDynamics, Inc.
QEY · Mechanical Thrombolysis Catheter · 21d
Cleared Nov 18, 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K032784 · Intra Luminal Therapeutics, Inc.
DQY · Catheter, Percutaneous · 71d
Cleared Nov 14, 2003
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · Medtronic Perfusion Systems
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 11d
Cleared Nov 13, 2003
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K032691 · Zoll Medical Corp
LDD · Dc-defibrillator, Low-energy, (including Paddles) · 72d
Cleared Nov 12, 2003
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
K033021 · Kimberly-Clark Corp.
DWJ · System, Thermal Regulating · 47d
Cleared Nov 12, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K033304 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 29d
Cleared Nov 10, 2003
STAR (LUNAR SERIES) MONITORING SYSTEM
K032867 · Larsen & Toubro Limited
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 56d
Cleared Nov 10, 2003
PLANET MONITORING SYSTEM
K032871 · Larsen & Toubro Limited
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 56d
Cleared Nov 06, 2003
APEXPRO FH TELEMETRY SYSTEM
K033365 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 16d
Cleared Nov 05, 2003
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K032439 · Zoll Medical Corp
MKJ · Automated External Defibrillators (non-wearable) · 90d
Cleared Nov 05, 2003
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K033247 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 29d
Cleared Nov 05, 2003
SELECTIVA SB GUIDEWIRE
K033321 · Neometrics, Inc.
DQX · Wire, Guide, Catheter · 21d
Cleared Nov 05, 2003
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
K033416 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 9d
Cleared Nov 03, 2003
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946 · Edwards Lifesciences, LLC
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 132d
Cleared Oct 31, 2003
ZOLL M SERIES NIBP OPTION
K032363 · Zoll Medical Corp
DXN · System, Measurement, Blood-pressure, Non-invasive · 92d
Cleared Oct 31, 2003
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · Cook, Inc.
DTK · Filter, Intravascular, Cardiovascular · 86d
Cleared Oct 31, 2003
PHERON PTA CATHETER
K033217 · Biotronik, Inc.
DQY · Catheter, Percutaneous · 28d
Cleared Oct 31, 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
K033264 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 22d
Cleared Oct 31, 2003
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K033305 · Draeger Medical Systems, Inc.
DSI · Detector And Alarm, Arrhythmia · 17d
Cleared Oct 30, 2003
A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS
K032499 · A&D Engineering, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 78d
Cleared Oct 30, 2003
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · Ge Medical Systems Information Technologies
DQK · Computer, Diagnostic, Programmable · 77d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · Smith & Nephew, Inc.
DWQ · Stripper, Vein, External · 86d
Cleared Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078 · Datex-Ohmeda
MSX · System, Network And Communication, Physiological Monitors · 30d
Cleared Oct 23, 2003
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
K030627 · C.R. Bard, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 238d
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · Cook, Inc.
DQY · Catheter, Percutaneous · 30d

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All categories 14952 DXN System, Measurement, Blood-pressure, Non-invasive 938 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