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
14956 Cardiovascular devices
7851–7875 of 14956
Cleared Mar 20, 2003
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp.
DTQ · Console, Heart-lung Machine, Cardiopulmonary Bypass · 196d
Cleared Mar 18, 2003
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
K030005 · Vanguard Medical Concepts, Inc.
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 75d
Cleared Mar 14, 2003
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077 · Gish Biomedical, Inc.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 65d
Cleared Mar 12, 2003
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR
K030038 · Philips Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 65d
Cleared Mar 11, 2003
REPROCESSED COMPRESSION SLEEVES
K024087 · Alliance Medical Corp.
JOW · Sleeve, Limb, Compressible · 90d
Cleared Mar 11, 2003
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
K030476 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 26d
Cleared Mar 07, 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp.
JOW · Sleeve, Limb, Compressible · 87d
Cleared Mar 07, 2003
NAUTICA MICRO CATHETER, MODEL 105-5094-153
K024122 · Micro Therapeutics, Inc.
KRA · Catheter, Continuous Flush · 81d
Cleared Mar 06, 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · Cobe Cardiovascular, Inc.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 22d
Cleared Mar 05, 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · Gish Biomedical, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 86d
Cleared Mar 05, 2003
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K030449 · Terumo Corp.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 22d
Cleared Mar 04, 2003
ANESTHESIA MONITOR
K030105 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 50d
Cleared Mar 04, 2003
SKINTACT ECG TAB ELECTRODE
K030509 · Leonhard Lang GmbH
DRX · Electrode, Electrocardiograph · 13d
Cleared Feb 26, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K030431 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 16d
Cleared Feb 14, 2003
STEERABLE GUIDEWIRE
K022813 · Lake Region Mfg., Inc.
DQX · Wire, Guide, Catheter · 172d
Cleared Feb 12, 2003
A16 BLOOD FLOW MEASUREMENT SYSTEM
K023707 · D. E. Hokanson, Inc.
JOM · Plethysmograph, Photoelectric, Pneumatic Or Hydraulic · 100d
Cleared Feb 12, 2003
WELCH ALLYN VITAL SIGN MONITOR WITH MP506
K024005 · Welch Allyn, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 70d
Cleared Feb 11, 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 12d
Cleared Feb 03, 2003
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
K024118 · Micro Therapeutics, Inc.
KRA · Catheter, Continuous Flush · 49d
Cleared Jan 31, 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · Oscor, Inc.
DTB · Permanent Pacemaker Electrode · 53d
Cleared Jan 27, 2003
ERA 3000
K022360 · Biotronik, Inc.
DTA · Tester, Pacemaker Electrode Function · 192d
Cleared Jan 24, 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878 · Medtronic Vascular
NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection · 64d
Cleared Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · Guidant Corp.
DQX · Wire, Guide, Catheter · 21d
Cleared Jan 17, 2003
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689 · Card Guard Scientific Survival , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 77d
Cleared Jan 17, 2003
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
K023745 · Sechrist Industries, Inc.
DTX · Gas Control Unit, Cardiopulmonary Bypass · 71d

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 14956 DXN System, Measurement, Blood-pressure, Non-invasive 939 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