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
14828 Cardiovascular devices
5701–5725 of 14828
Cleared Aug 07, 2009
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
K092075 · St. Jude Medical, Cardiac Rhythm Management Divisi
DQY · Catheter, Percutaneous · 29d
Cleared Aug 07, 2009
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
K092064 · Biosense Webster, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 30d
Cleared Aug 07, 2009
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
K091856 · Conmed Corporation
DRX · Electrode, Electrocardiograph · 45d
Cleared Aug 07, 2009
CRYOPATCH SG PULMONARY HEMI-ARTERY
K091626 · Cryolife, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 65d
Cleared Aug 07, 2009
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
K091548 · Amco International Manufacturing & Design, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 72d
Cleared Aug 07, 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · Cook, Inc.
DQX · Wire, Guide, Catheter · 89d
Cleared Aug 07, 2009
HORIZON XVU
K091165 · Mennen Medical , Ltd.
DQK · Computer, Diagnostic, Programmable · 107d
Cleared Aug 07, 2009
SIGNAL
K090493 · Zargis Medical Corp.
DQD · Stethoscope, Electronic · 163d
Cleared Aug 04, 2009
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
K091062 · Gish Biomedical, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 112d
Cleared Jul 31, 2009
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K091500 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 71d
Cleared Jul 31, 2009
HERO VASCULAR ACCESS DEVICE
K091491 · Hemosphere, Inc.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 72d
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
K092045 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 24d
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962
K091997 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 28d
Cleared Jul 30, 2009
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
K091966 · Angioscore, Inc.
PNO · Catheter, Percutaneous, Cutting/scoring · 29d
Cleared Jul 30, 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
K091961 · Concentric Medical, Inc.
DQO · Catheter, Intravascular, Diagnostic · 29d
Cleared Jul 30, 2009
RECRUIT MICROCATHETER
K091563 · Reverse Medical Corporation
MMX · Device, Percutaneous Retrieval · 63d
Cleared Jul 30, 2009
NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER
K090918 · Nfocus Neuromedical, Inc.
DQY · Catheter, Percutaneous · 120d
Cleared Jul 30, 2009
AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002
K090867 · Ep Dynamics, Inc.
DYB · Introducer, Catheter · 121d
Cleared Jul 30, 2009
MEDOS HILITE RESERVOIR, MODEL: 4030
K083131 · Gish Biomedical, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 280d
Cleared Jul 29, 2009
HEART-EXERCISE
K091594 · Ge Medical Systems Information Technologies GmbH
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 57d
Cleared Jul 27, 2009
WALK400H
K091054 · Et Medical Devices Spa
MWJ · Electrocardiograph, Ambulatory (without Analysis) · 105d
Cleared Jul 24, 2009
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
K091985 · Ivy Biomedical Systems, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 22d
Cleared Jul 24, 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
K091513 · Edan Instruments, Inc.
DPS · Electrocardiograph · 63d
Cleared Jul 24, 2009
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
K081603 · Heartforce Medical, Inc.
DXR · Ballistocardiograph · 413d
Cleared Jul 21, 2009
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · iRhythm Technologies, Inc.
DQK · Computer, Diagnostic, Programmable · 98d

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All categories 14828 DXN System, Measurement, Blood-pressure, Non-invasive 929 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 699 DYB Introducer, Catheter 630 DPS Electrocardiograph 438 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 409 DQO Catheter, Intravascular, Diagnostic 400 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 375 LIT Catheter, Angioplasty, Peripheral, Transluminal 361 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 276 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 270