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
14890 Cardiovascular devices
6676–6700 of 14890
Cleared Dec 15, 2006
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
K062577 · Tz Medical, Inc.
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 106d
Cleared Dec 15, 2006
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
K061680 · Atrium Medical Corp.
DQY · Catheter, Percutaneous · 183d
Cleared Dec 14, 2006
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
K063371 · Vascular Solutions, Inc.
QEZ · Aspiration Thrombectomy Catheter · 36d
Cleared Dec 14, 2006
SUPRACOR BALLOON CATHETER
K062582 · Abiomed, Inc.
DSP · System, Balloon, Intra-aortic And Control · 105d
Cleared Dec 13, 2006
ZOLL E SERIES WITH REAL CPR HELP
K062177 · ZOLL Medical Corporation
MKJ · Automated External Defibrillators (non-wearable) · 135d
Cleared Dec 12, 2006
VASCUTRAK PTA DILATION CATHETER
K063657 · Ymed, Inc.
PNO · Catheter, Percutaneous, Cutting/scoring · 4d
Cleared Dec 12, 2006
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
K052465 · Heartsine Technologies, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 460d
Cleared Dec 11, 2006
MODIFICATION TO MODEL 750 SERIES MONITOR
K063087 · Cas Medical Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 62d
Cleared Dec 11, 2006
ORI F6T DRY ECG MONITORING ELECTRODE
K062760 · Orbital Research, Inc.
DRX · Electrode, Electrocardiograph · 87d
Cleared Dec 08, 2006
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
K061902 · Inditherm Medical
DWJ · System, Thermal Regulating · 156d
Cleared Dec 07, 2006
PRN THERMALCARE, MODEL 3000
K062794 · American Healthcare Products, Inc.
DWJ · System, Thermal Regulating · 80d
Cleared Dec 07, 2006
MERCATOR MICROSYRINGE II INFUSION CATHETER
K062752 · Mercator Medsystems, Inc.
KRA · Catheter, Continuous Flush · 84d
Cleared Dec 07, 2006
MODIFICATION TO: SMITHWICK CAROTID SHUNT
K061484 · Mcpherson Enterprises, Inc.
DXC · Clamp, Vascular · 191d
Cleared Dec 06, 2006
I-SCOPE 200
K062364 · Dongjin Medical Co., Ltd.
DQD · Stethoscope, Electronic · 114d
Cleared Dec 06, 2006
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
K062324 · Ge Healthcare
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 119d
Cleared Dec 06, 2006
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
K051817 · Cardiva Medical, Inc.
DXC · Clamp, Vascular · 519d
Cleared Dec 05, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
K063313 · Boston Scientific Corp
NTE · Temporary Carotid Catheter For Embolic Capture · 33d
Cleared Dec 04, 2006
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
K063419 · Welch Allyn Protocol, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 21d
Cleared Dec 04, 2006
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · Radi Medical Systems AB
DXO · Transducer, Pressure, Catheter Tip · 80d
Cleared Dec 01, 2006
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
K063012 · Ncontact Surgical, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 60d
Cleared Nov 30, 2006
MAPMATE
K063277 · Ep Medsystems, Inc.
DQK · Computer, Diagnostic, Programmable · 30d
Cleared Nov 30, 2006
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
K062340 · Cardio-Optics, Inc.
LYK · Angioscope · 112d
Cleared Nov 30, 2006
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
K062271 · Philips Medical Systems
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 115d
Cleared Nov 30, 2006
VASOPRESS DVT SYSTEM, MODEL VP500D
K061814 · Compression Therapy Concepts, Inc.
JOW · Sleeve, Limb, Compressible · 156d
Cleared Nov 22, 2006
MICRO-INFUSION SYSTEM
K062507 · Ekos Corp.
QEY · Mechanical Thrombolysis Catheter · 86d

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All categories 14890 DXN System, Measurement, Blood-pressure, Non-invasive 931 DQY Catheter, Percutaneous 788 DQX Wire, Guide, Catheter 700 DYB Introducer, Catheter 633 DPS Electrocardiograph 440 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 411 DQO Catheter, Intravascular, Diagnostic 401 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 376 LIT Catheter, Angioplasty, Peripheral, Transluminal 363 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 307 JOW Sleeve, Limb, Compressible 281 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 273