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
2801–2825 of 4339
Cleared Mar 27, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
K123762 · Medtronic, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 110d
Cleared Jan 29, 2013
PACIFIC PLUS
K123358 · Medtronic Vascular
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 90d
Cleared Jan 22, 2013
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
K123314 · Medtronic, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 89d
Cleared Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
K122914 · Medtronic, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 110d
Cleared Dec 14, 2012
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
K122827 · Medtronic, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 91d
Cleared Dec 13, 2012
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
K123448 · Medtronic, Inc.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 35d
Cleared Dec 07, 2012
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760 · Medtronic, Inc.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 88d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp
MAV · Syringe, Balloon Inflation · 29d
Cleared Nov 02, 2012
BARD PTV DILATATION CATHETER
K122367 · C.R. Bard, Inc.
OMZ · Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter · 88d
Cleared Nov 02, 2012
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
K121878 · Medtronic, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 127d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · Boston Scientific Corporation
DQX · Wire, Guide, Catheter · 28d
Cleared Oct 22, 2012
ATLAS GOLD PTA DILATATION CATHETER
K122984 · C.R. Bard, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 26d
Cleared Oct 19, 2012
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
K122913 · Medtronic, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 28d
Cleared Oct 12, 2012
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
K122811 · Medtronic, Inc.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 29d
Cleared Sep 25, 2012
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
K121219 · Medtronic, Inc.
DQY · Catheter, Percutaneous · 155d
Cleared Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
K121694 · Boston Scientific Corp
DQO · Catheter, Intravascular, Diagnostic · 99d
Cleared Sep 14, 2012
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
K100645 · Medtronic, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 924d
Cleared Sep 13, 2012
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · Boston Scientific Corp
MCW · Catheter, Peripheral, Atherectomy · 87d
Cleared Aug 31, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K121196 · Boston Scientific Corp
LOX · Catheters, Transluminal Coronary Angioplasty, Percutaneous · 134d
Cleared Aug 30, 2012
RUBICON 18 SUPPORT CATHETER
K122394 · Boston Scientific Corp
DQY · Catheter, Percutaneous · 23d
Cleared Aug 17, 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
K120008 · Medline Industries, Inc.
DQO · Catheter, Intravascular, Diagnostic · 227d
Cleared Aug 13, 2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · Boston Scientific Corp
LOX · Catheters, Transluminal Coronary Angioplasty, Percutaneous · 68d
Cleared Jul 25, 2012
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
K120988 · Medtronic, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 114d
Cleared Jul 13, 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 28d
Cleared Jul 11, 2012
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
K121856 · C.R. Bard, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 15d

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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