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
4339 Cardiovascular devices
2826–2850 of 4339
Cleared Jun 14, 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · Medtronic, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 29d
Cleared Jun 07, 2012
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · Medtronic, Inc.
QEZ · Aspiration Thrombectomy Catheter · 83d
Cleared Jun 06, 2012
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
K120987 · Medtronic, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 65d
Cleared May 25, 2012
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
K120612 · Medtronic, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 86d
Cleared May 22, 2012
AMPHIRION PLUS PTA CATHETER
K121265 · Medtronic, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 26d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · Boston Scientific Corp
DQO · Catheter, Intravascular, Diagnostic · 94d
Cleared May 04, 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · Cordis Corp.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 221d
Cleared May 03, 2012
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
K120704 · 3M Company
DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency · 56d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694 · Boston Scientific Corp
MAV · Syringe, Balloon Inflation · 27d
Cleared Apr 03, 2012
MEDLINE STOPCOCK AND MANIFOLD
K120069 · Medline Industries, Inc.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 85d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · Boston Scientific Corp
DQO · Catheter, Intravascular, Diagnostic · 6d
Cleared Mar 22, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K113220 · Boston Scientific Corporation
LOX · Catheters, Transluminal Coronary Angioplasty, Percutaneous · 142d
Cleared Jan 25, 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845 · Medtronic, Inc.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 28d
Cleared Jan 17, 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 90d
Cleared Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · Boston Scientific Corporation
KRD · Device, Vascular, For Promoting Embolization · 30d
Cleared Dec 02, 2011
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · Medtronic, Inc.
DXS · Gauge, Pressure, Coronary, Cardiopulmonary Bypass · 30d
Cleared Oct 27, 2011
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
K112917 · Medtronic, Inc.
DQY · Catheter, Percutaneous · 24d
Cleared Oct 24, 2011
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
K112497 · C.R. Bard, Inc.
DTK · Filter, Intravascular, Cardiovascular · 56d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745 · Boston Scientific Corporation
DQX · Wire, Guide, Catheter · 27d
Cleared Aug 24, 2011
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
K102511 · C.R. Bard, Inc.
DTK · Filter, Intravascular, Cardiovascular · 357d
Cleared Aug 17, 2011
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc.
PDU · Catheter For Crossing Total Occlusions · 6d
Cleared Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103 · Boston Scientific Corp
KRD · Device, Vascular, For Promoting Embolization · 21d
Cleared Jul 27, 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
K111972 · Medtronic, Inc.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 16d
Cleared Jul 19, 2011
MEDLINE VESSEL CANNULA
K111147 · Medline Industries, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 85d
Cleared Jul 13, 2011
VACCESS PTA DILATATION CATHETER
K111850 · C.R. Bard, Inc.
DQY · Catheter, Percutaneous · 14d

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All categories 4339 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 DTZ Oxygenator, Cardiopulmonary Bypass 72 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 71