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.

18151
Total
18097
Cleared
152d
Avg (2y)
1976
Since
15004 Cardiovascular devices
8801–8825 of 15004
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
K992387 · Rossmax International , Ltd.
DPW · Flowmeter, Blood, Cardiovascular · 15d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
K992388 · Rossmax International , Ltd.
DPW · Flowmeter, Blood, Cardiovascular · 15d
Cleared Jul 30, 1999
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
K983802 · Lucas Medical, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 275d
Cleared Jul 30, 1999
AVE GL-1 GUIDING CATHETER
K984482 · Arterial Vascular Engineering Massachusetts, Inc.
DQY · Catheter, Percutaneous · 226d
Cleared Jul 30, 1999
HT, MODEL HT PB
K990142 · Sulzer Oscor, Inc.
DTB · Permanent Pacemaker Electrode · 192d
Cleared Jul 28, 1999
VOYAGER QUAD CANNULA
K983270 · Cardiothoracic Systems, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 314d
Cleared Jul 28, 1999
MODIFICATION TO ZYMED HOLTER 2000
K992197 · Zymed Medical Instrumentation
MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm · 28d
Cleared Jul 27, 1999
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
K984627 · Arterial Vascular Engineering, Inc.
DQO · Catheter, Intravascular, Diagnostic · 209d
Cleared Jul 23, 1999
PVS 1400 GUIDEWIRE
K990823 · Precision Vascular Systems, Inc.
DQX · Wire, Guide, Catheter · 133d
Cleared Jul 23, 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K992231 · Merit Medical Systems, Inc.
QEY · Mechanical Thrombolysis Catheter · 21d
Cleared Jul 22, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION
K990476 · Hewlett-Packard GmbH
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 156d
Cleared Jul 21, 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 78d
Cleared Jul 21, 1999
SCIMED ANGIOGRAPHIC CATHETERS
K992142 · Scimed
DQO · Catheter, Intravascular, Diagnostic · 27d
Cleared Jul 21, 1999
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
K992328 · Meditec Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 9d
Cleared Jul 20, 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · Deroyal Industries, Inc.
DXQ · Blood Pressure Cuff · 78d
Cleared Jul 19, 1999
MEDITRON STETHOSCOPE SYSTEM
K991367 · Meditron AS
DQD · Stethoscope, Electronic · 90d
Cleared Jul 15, 1999
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
K983940 · Adam Spence Corp.
DYB · Introducer, Catheter · 252d
Cleared Jul 15, 1999
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
K991001 · Ep Medsystems
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 112d
Cleared Jul 14, 1999
SOLAR 9500 INFORMATION MONITOR
K990068 · General Electric Medical Systems Information Techn
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 187d
Cleared Jul 09, 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · W.L. Gore & Associates, Inc.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 60d
Cleared Jul 08, 1999
ATLAS MONITOR
K984033 · Welch Allyn, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 238d
Cleared Jul 08, 1999
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
K991211 · Reynolds Medical , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 90d
Cleared Jul 02, 1999
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
K991170 · Edwards Lifesciences Research Medical
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 86d
Cleared Jul 01, 1999
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169 · Biotronik, Inc.
DTB · Permanent Pacemaker Electrode · 85d
Cleared Jun 29, 1999
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
K984586 · Fresenius Hemotechnology, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 187d

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All categories 15004 DXN System, Measurement, Blood-pressure, Non-invasive 943 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 703 DYB Introducer, Catheter 638 DPS Electrocardiograph 445 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 414 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 378 LIT Catheter, Angioplasty, Peripheral, Transluminal 367 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 339 DSI Detector And Alarm, Arrhythmia 310 JOW Sleeve, Limb, Compressible 289 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275