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
3001–3025 of 4339
Cleared Jun 03, 2003
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
K031000 · C.R. Bard, Inc.
DQK · Computer, Diagnostic, Programmable · 64d
Cleared May 29, 2003
PACEART SYSTEM
K024278 · Medtronic Vascular
DPS · Electrocardiograph · 157d
Cleared May 22, 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
K031518 · Medtronic Vascular
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 7d
Cleared May 22, 2003
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular
DTB · Permanent Pacemaker Electrode · 30d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779 · Medtronic Vascular
DQY · Catheter, Percutaneous · 44d
Cleared Apr 22, 2003
STEELEX ELECTRODE SET
K030556 · Aesculap, Inc.
LDF · Electrode, Pacemaker, Temporary · 60d
Cleared Mar 26, 2003
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201 · Medtronic Vascular
NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection · 64d
Cleared Mar 21, 2003
INFINITY EXPLORER
K030615 · Siemens Medical Solutions USA, Inc.
MSX · System, Network And Communication, Physiological Monitors · 23d
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 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 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126 · Abbott Laboratories
DQO · Catheter, Intravascular, Diagnostic · 29d
Cleared Jan 08, 2003
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
K024069 · Medtronic Vascular
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 29d
Cleared Dec 30, 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024035 · Medtronic Vascular
DQY · Catheter, Percutaneous · 24d
Cleared Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024032 · Medtronic Vascular
DQY · Catheter, Percutaneous · 24d
Cleared Dec 18, 2002
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
K024108 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 5d
Cleared Dec 11, 2002
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · Ethicon, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 20d
Cleared Dec 11, 2002
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc.
DXC · Clamp, Vascular · 349d
Cleared Nov 27, 2002
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236 · C.R. Bard, Inc.
DTK · Filter, Intravascular, Cardiovascular · 139d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681 · Boston Scientific Corp
DQO · Catheter, Intravascular, Diagnostic · 25d
Cleared Nov 06, 2002
8F LAUNCHER GUIDE CATHETER
K023402 · Medtronic Vascular
DQY · Catheter, Percutaneous · 27d
Cleared Nov 04, 2002
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
K023569 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 11d
Cleared Oct 29, 2002
EXPORT ASPIRATION CATHETER
K023303 · Medtronic Vascular
NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection · 26d
Cleared Oct 18, 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · Cordis Corp.
DTK · Filter, Intravascular, Cardiovascular · 29d
Cleared Oct 09, 2002
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
K022238 · Medtronic Vascular
DWS · Instruments, Surgical, Cardiovascular · 90d
Cleared Sep 25, 2002
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
K022889 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 26d

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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