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
14951 Cardiovascular devices
7626–7650 of 14951
Cleared Apr 02, 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K033875 · Cook, Inc.
DQY · Catheter, Percutaneous · 109d
Cleared Mar 26, 2004
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
K033050 · Medtronic Vascular
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 179d
Cleared Mar 26, 2004
CONTOUR SE MICROSPHERES
K034068 · Boston Scientific Corp
KRD · Device, Vascular, For Promoting Embolization · 86d
Cleared Mar 23, 2004
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
K024213 · Siemens Medical Solutions USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 459d
Cleared Mar 22, 2004
MODEL AVANT 2120 PULSE OXIMETER AND NIBP
K031487 · Nonin Medical, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 315d
Cleared Mar 22, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
K033694 · Draeger Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 119d
Cleared Mar 19, 2004
PEDIATRIC AORTIC ROOT CANNULA
K040173 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 53d
Cleared Mar 19, 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
K040229 · A&D Engineering, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 46d
Cleared Mar 18, 2004
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
K040481 · Intra Luminal Therapeutics, Inc.
DQY · Catheter, Percutaneous · 22d
Cleared Mar 15, 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286 · Ethox Corp.
DXQ · Blood Pressure Cuff · 38d
Cleared Mar 15, 2004
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
K040298 · Acist Medical Systems, Inc.
DXT · Injector And Syringe, Angiographic · 35d
Cleared Mar 15, 2004
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
K040355 · Gish Biomedical, Inc.
DTR · Heat-exchanger, Cardiopulmonary Bypass · 32d
Cleared Mar 11, 2004
PROGREAT
K033913 · Terumo Medical Corp.
KRA · Catheter, Continuous Flush · 85d
Cleared Mar 09, 2004
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER
K033807 · Draeger Medical Systems, Inc.
DRQ · Amplifier And Signal Conditioner, Transducer Signal · 92d
Cleared Mar 03, 2004
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 181d
Cleared Mar 03, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K040037 · Intra Luminal Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 54d
Cleared Mar 03, 2004
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
K040210 · Terumo Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 33d
Cleared Mar 03, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
K040357 · Philips Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 19d
Cleared Mar 02, 2004
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
K033881 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 78d
Cleared Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · Ev3, Inc.
DQX · Wire, Guide, Catheter · 19d
Cleared Mar 01, 2004
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · Terumo Cardiovascular Systems Corp.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 54d
Cleared Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · Arrow Intl., Inc.
DQX · Wire, Guide, Catheter · 41d
Cleared Mar 01, 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304 · Philips Medizin Systeme Boeblingen GmbH
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 21d
Cleared Feb 27, 2004
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K032421 · Ambu, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 206d
Cleared Feb 27, 2004
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
K033771 · Bio-Detek, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 86d

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All categories 14951 DXN System, Measurement, Blood-pressure, Non-invasive 938 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 638 DPS Electrocardiograph 443 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 402 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 365 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 337 DSI Detector And Alarm, Arrhythmia 309 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 274