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
7676–7700 of 14952
Cleared Dec 19, 2003
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K032763 · Vascular Solutions, Inc.
QEZ · Aspiration Thrombectomy Catheter · 105d
Cleared Dec 19, 2003
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
K033159 · LeMaitre Vascular, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 80d
Cleared Dec 19, 2003
HYDROPHILIC GUIDEWIRE
K033758 · Lake Region Mfg., Inc.
DQX · Wire, Guide, Catheter · 17d
Cleared Dec 18, 2003
MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 24d
Cleared Dec 12, 2003
PROGREAT
K033583 · Terumo Medical Corp.
DQO · Catheter, Intravascular, Diagnostic · 29d
Cleared Dec 11, 2003
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
K033424 · Transonic Systems, Inc.
DPW · Flowmeter, Blood, Cardiovascular · 49d
Cleared Dec 11, 2003
INFINITY GAMMAXL
K033600 · Draeger Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 27d
Cleared Dec 11, 2003
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · Cobe Cardiovascular, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 21d
Cleared Dec 11, 2003
M2376A PHILIPS DEVICE LINK SYSTEM
K033680 · Philips Medical Systems
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 17d
Cleared Dec 11, 2003
GLIDESHEATH
K033681 · Terumo Corp.
DYB · Introducer, Catheter · 17d
Cleared Dec 11, 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033708 · Intra Luminal Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 15d
Cleared Dec 11, 2003
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
K033714 · Dideco S.P.A.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 15d
Cleared Dec 10, 2003
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
K031949 · Baylis Medical Co., Inc.
DXF · Catheter, Septostomy · 169d
Cleared Dec 08, 2003
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613 · Biotronik, Inc.
DTA · Tester, Pacemaker Electrode Function · 21d
Cleared Dec 04, 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124 · Datex-Ohmeda, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 240d
Cleared Dec 04, 2003
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900 · Edwards Lifesciences, LLC
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 78d
Cleared Nov 26, 2003
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
K033281 · Datex-Ohmeda
MSX · System, Network And Communication, Physiological Monitors · 43d
Cleared Nov 25, 2003
MONITOR, MODEL HSM-00200
K031153 · Arrow Intl., Inc.
DPW · Flowmeter, Blood, Cardiovascular · 228d
Cleared Nov 25, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
K031340 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 211d
Cleared Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K033492 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 20d
Cleared Nov 21, 2003
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K031842 · Intra Luminal Therapeutics, Inc.
PDU · Catheter For Crossing Total Occlusions · 158d
Cleared Nov 21, 2003
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
K033441 · Boston Scientific Corp
DQY · Catheter, Percutaneous · 23d
Cleared Nov 21, 2003
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER
K033444 · Philips Medical Systems
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 23d
Cleared Nov 19, 2003
COOK CODA BALLOON CATHETER
K032869 · Cook, Inc.
DQY · Catheter, Percutaneous · 65d
Cleared Nov 19, 2003
SCOUT PRO
K033320 · Biotronik, Inc.
DQY · Catheter, Percutaneous · 35d

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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