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
14926 Cardiovascular devices
7101–7125 of 14926
Cleared Nov 30, 2005
ASAHI PTCA GUIDE WIRE
K052339 · Asahi Intecc Co., Ltd.
DQX · Wire, Guide, Catheter · 96d
Cleared Nov 25, 2005
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
K052578 · Bard Peripheral Vascular, Inc.
DTK · Filter, Intravascular, Cardiovascular · 66d
Cleared Nov 23, 2005
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A
K052872 · Taidoc Technology Corporation
DXN · System, Measurement, Blood-pressure, Non-invasive · 43d
Cleared Nov 23, 2005
MREYE EMBOLIZATION COIL
K052834 · Cook, Inc.
KRD · Device, Vascular, For Promoting Embolization · 48d
Cleared Nov 23, 2005
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
K052257 · Vascular Solutions, Inc.
DQY · Catheter, Percutaneous · 97d
Cleared Nov 22, 2005
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
K053027 · Welch Allyn, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 26d
Cleared Nov 22, 2005
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977 · Ge Healthcare
DQK · Computer, Diagnostic, Programmable · 29d
Cleared Nov 22, 2005
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
K052784 · Welch Allyn, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 50d
Cleared Nov 22, 2005
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 69d
Cleared Nov 21, 2005
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
K052381 · Zerusa Limited
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 83d
Cleared Nov 18, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
K052961 · Philips Medical Systems
DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency · 28d
Cleared Nov 18, 2005
MEDITECH MODEL ABPM-04
K051149 · Meditech Kft.
DXN · System, Measurement, Blood-pressure, Non-invasive · 198d
Cleared Nov 17, 2005
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
K052899 · Genesee Biomedical, Inc.
KRH · Ring, Annuloplasty · 34d
Cleared Nov 17, 2005
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
K052565 · Genesee Biomedical, Inc.
KRH · Ring, Annuloplasty · 59d
Cleared Nov 16, 2005
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
K052603 · Alliance Medical Corp.
NLH · Catheter, Recording, Electrode, Reprocessed · 56d
Cleared Nov 16, 2005
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K052414 · Alliance Medical Corp.
NLH · Catheter, Recording, Electrode, Reprocessed · 75d
Cleared Nov 16, 2005
INFINITY ALPHA
K051658 · Draeger Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 148d
Cleared Nov 10, 2005
JOSTRA HLM TUBING SET
K053025 · Maquet Cardiopulmonary, AG
DWE · Tubing, Pump, Cardiopulmonary Bypass · 14d
Cleared Nov 10, 2005
CG FUTURE ANNULOPLASTY BAND
K052860 · Medtronic Heart Valves
KRH · Ring, Annuloplasty · 30d
Cleared Nov 10, 2005
ANGIOJET XPEEDIOR 120 CATHETER
K052256 · Possis Medical, Inc.
QEZ · Aspiration Thrombectomy Catheter · 84d
Cleared Nov 10, 2005
EXTENDED MEASUREMENTS SYSTEM
K051450 · Inovise Medical, Inc.
DQD · Stethoscope, Electronic · 161d
Cleared Nov 07, 2005
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280 · Boston Scientific Corp
NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection · 77d
Cleared Nov 04, 2005
MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K052791 · Invatec Innovative Technologies, S.R.L.
DQY · Catheter, Percutaneous · 32d
Cleared Nov 04, 2005
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
K051312 · Veryan Medical Limited
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 169d
Cleared Nov 04, 2005
INVOS SYSTEM
K051274 · Somanetics Corp.
MUD · Oximeter, Tissue Saturation · 171d

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 14926 DXN System, Measurement, Blood-pressure, Non-invasive 934 DQY Catheter, Percutaneous 791 DQX Wire, Guide, Catheter 700 DYB Introducer, Catheter 636 DPS Electrocardiograph 442 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 336 DSI Detector And Alarm, Arrhythmia 308 JOW Sleeve, Limb, Compressible 284 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 274