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.

18027
Total
17975
Cleared
150d
Avg (2y)
1976
Since
4345 Cardiovascular devices
3051–3075 of 4345
Cleared Sep 28, 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · C.R. Bard, Inc.
DQY · Catheter, Percutaneous · 29d
Cleared Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · Medtronic Vascular
DYG · Catheter, Flow Directed · 43d
Cleared Aug 28, 2001
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
K012130 · Medtronic Vascular
DQY · Catheter, Percutaneous · 50d
Cleared Aug 28, 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083 · Medtronic Vascular
DQY · Catheter, Percutaneous · 56d
Cleared Aug 23, 2001
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · Medtronic Vascular
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 16d
Cleared Aug 21, 2001
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc.
DXC · Clamp, Vascular · 159d
Cleared Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461 · Siemens Medical Solutions USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 16d
Cleared Aug 14, 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 14, 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
K012459 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 14, 2001
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
K012458 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 14, 2001
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
K012454 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 14, 2001
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · Boston Scientific Corp
DQX · Wire, Guide, Catheter · 55d
Cleared Jul 20, 2001
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
K012016 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 22d
Cleared Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular
KRH · Ring, Annuloplasty · 66d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · Medtronic Vascular
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 25d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · Boston Scientific Corp
DQY · Catheter, Percutaneous · 90d
Cleared Jun 15, 2001
CORDIS M3 PTA DILATATION CATHETER
K003920 · Cordis Corp.
DQY · Catheter, Percutaneous · 178d
Cleared Jun 06, 2001
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · Cordis Corp.
DTK · Filter, Intravascular, Cardiovascular · 146d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217 · Abbott Laboratories
DQO · Catheter, Intravascular, Diagnostic · 26d
Cleared May 04, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K011098 · Medtronic Vascular
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 23d
Cleared Apr 05, 2001
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular
DRB · Stylet, Catheter · 10d
Cleared Mar 27, 2001
3M LITTMANN
K003723 · 3M Company
DQD · Stethoscope, Electronic · 113d
Cleared Mar 20, 2001
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · Siemens Medical Solutions USA, Inc.
DRQ · Amplifier And Signal Conditioner, Transducer Signal · 15d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · Boston Scientific Corp
DQK · Computer, Diagnostic, Programmable · 125d

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 4345 DXN System, Measurement, Blood-pressure, Non-invasive 241 DQY Catheter, Percutaneous 233 DYB Introducer, Catheter 194 DQX Wire, Guide, Catheter 188 DTB Permanent Pacemaker Electrode 187 DQK Computer, Diagnostic, Programmable 165 LIT Catheter, Angioplasty, Peripheral, Transluminal 138 DXY Implantable Pacemaker Pulse-generator 134 DQO Catheter, Intravascular, Diagnostic 121 QEW Peripheral Mechanical Thrombectomy With Aspiration 118 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 103 JOW Sleeve, Limb, Compressible 86 DPS Electrocardiograph 80 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 77 DTZ Oxygenator, Cardiopulmonary Bypass 72