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
14841 Cardiovascular devices
5876–5900 of 14841
Cleared Mar 09, 2009
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
K081081 · Zoll Medical Corporation, World Wide Headquarters
MKJ · Automated External Defibrillators (non-wearable) · 327d
Cleared Mar 06, 2009
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
K082528 · Noble Anesthesia-Air, Inc.
DQD · Stethoscope, Electronic · 185d
Cleared Mar 03, 2009
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
K090274 · Micrus Endovascular Corporation
DQX · Wire, Guide, Catheter · 27d
Cleared Mar 02, 2009
REEKROSS FAMILY OR OTW PTA CATHETERS
K083596 · ClearStream Technologies , Ltd.
DQY · Catheter, Percutaneous · 87d
Cleared Feb 27, 2009
CONCERTO DETACHABLE COIL SYSTEM
K090046 · Micro Therapeutics, Inc.
KRD · Device, Vascular, For Promoting Embolization · 51d
Cleared Feb 27, 2009
SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598
K083395 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 102d
Cleared Feb 27, 2009
PROTRON TECHNOLOGIES, LLC STETHOTRON
K082771 · Protron Technologies, LLC
DQD · Stethoscope, Electronic · 158d
Cleared Feb 25, 2009
TAD AND TAD II TAPERED GUIDE WIRES
K083732 · Abbott Vascular
DQX · Wire, Guide, Catheter · 71d
Cleared Feb 25, 2009
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
K083683 · Genesee Biomedical, Inc.
KRH · Ring, Annuloplasty · 75d
Cleared Feb 25, 2009
INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5
K082583 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 170d
Cleared Feb 23, 2009
.035 LOC GUIDE WIRE EXTENSION
K083713 · Abbott Vascular
DQX · Wire, Guide, Catheter · 70d
Cleared Feb 23, 2009
E.S TECK ( ELECTRO SENSOR TECK)
K083229 · Ld Technology, LLC
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 112d
Cleared Feb 20, 2009
STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
K083727 · Bridgepoint Medical
DQX · Wire, Guide, Catheter · 67d
Cleared Feb 19, 2009
MAC 800 RESTING ECG ANALYSIS SYSTEM
K090212 · Ge Medical Syst. Information Technologies
DPS · Electrocardiograph · 22d
Cleared Feb 19, 2009
CARDITTE MICROTEL
K082124 · Et Medical Devices Spa
DPS · Electrocardiograph · 206d
Cleared Feb 18, 2009
ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
K083735 · Medtechs, LLC
JOM · Plethysmograph, Photoelectric, Pneumatic Or Hydraulic · 64d
Cleared Feb 18, 2009
QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
K082117 · Maquet Cardiopulmonary, AG
DTZ · Oxygenator, Cardiopulmonary Bypass · 205d
Cleared Feb 17, 2009
NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
K090202 · Ncontact Surgical, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 21d
Cleared Feb 17, 2009
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
K083855 · Acumen Medical, Inc.
DYB · Introducer, Catheter · 55d
Cleared Feb 17, 2009
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
K083639 · Ge Medical Systems Information Technologies
DQK · Computer, Diagnostic, Programmable · 70d
Cleared Feb 13, 2009
CARDIAC TRIGGER, MODEL: CTM300
K083854 · Ivy Biomedical Systems, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 51d
Cleared Feb 13, 2009
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
K083309 · Zargis Medical Corp.
DQD · Stethoscope, Electronic · 95d
Cleared Feb 13, 2009
CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
K082930 · Cardiva Medical, Inc.
DXC · Clamp, Vascular · 135d
Cleared Feb 13, 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · Terumo Cardiovascular Systems Corp.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 184d
Cleared Feb 11, 2009
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
K083828 · Transoma
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 50d

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All categories 14841 DXN System, Measurement, Blood-pressure, Non-invasive 930 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 699 DYB Introducer, Catheter 631 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 376 LIT Catheter, Angioplasty, Peripheral, Transluminal 362 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 278 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 271