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
15021 Cardiovascular devices
9376–9400 of 15021
Cleared Sep 11, 1997
BIOZ SYSTEM & BIOZ PORTABLE
K972320 · Cardiodynamics International Corp.
DSB · Plethysmograph, Impedance · 80d
Cleared Sep 10, 1997
MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
K963725 · Card Guard , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 415d
Cleared Sep 10, 1997
S3 CYCLIC RPM CONTROL
K971520 · Stoeckert Instrumente
DWB · Pump, Blood, Cardiopulmonary Bypass, Roller Type · 138d
Cleared Sep 10, 1997
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
K972017 · Minntech Corp.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 103d
Cleared Sep 09, 1997
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
K970585 · Fukuda Denshi USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 207d
Cleared Sep 08, 1997
AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
K964238 · Aircast, Inc.
JOW · Sleeve, Limb, Compressible · 320d
Cleared Sep 08, 1997
CHASE THORACIC CATHETER
K971023 · Chase Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 172d
Cleared Sep 03, 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K964908 · Sorin Biomedical, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 268d
Cleared Sep 02, 1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113 · Boston Scientific Corp
DSP · System, Balloon, Intra-aortic And Control · 89d
Cleared Aug 29, 1997
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072 · Ela Medical, Inc.
DXY · Implantable Pacemaker Pulse-generator · 233d
Cleared Aug 29, 1997
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K970296 · Boston Scientific Corp
MCW · Catheter, Peripheral, Atherectomy · 214d
Cleared Aug 29, 1997
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
K970347 · Paladin Medical, Inc.
DTE · Pulse-generator, Pacemaker, External · 214d
Cleared Aug 28, 1997
INFUSASLEEVE IIA (IS-2A)
K972175 · Localmed, Inc.
QEY · Mechanical Thrombolysis Catheter · 80d
Cleared Aug 27, 1997
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K972970 · Graphic Controls Corp.
MKJ · Automated External Defibrillators (non-wearable) · 16d
Cleared Aug 26, 1997
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · Sorin Group Italia S.R.L.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 54d
Cleared Aug 25, 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
K972142 · Guidant Corp.
DQX · Wire, Guide, Catheter · 80d
Cleared Aug 22, 1997
CHASE BLOOD VESSEL SHUNT
K972665 · Chase Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 37d
Cleared Aug 21, 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
K964907 · Sorin Biomedical, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 255d
Cleared Aug 20, 1997
DM-400 HOLTER ECG CASSETTE RECORDER
K970298 · Diagnostic Monitoring
DSH · Recorder, Magnetic Tape, Medical · 205d
Cleared Aug 20, 1997
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
K972310 · Nihon Kohden America, Inc.
DPS · Electrocardiograph · 61d
Cleared Aug 19, 1997
ORIGIN CARDIAC STABLIZER OCCLUDER
K970611 · Origin Medsystems, Inc.
DXC · Clamp, Vascular · 182d
Cleared Aug 18, 1997
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
K965140 · Cardio Metrics, Inc.
DQX · Wire, Guide, Catheter · 238d
Cleared Aug 18, 1997
DINAMAP COMPACT MONITOR
K970182 · Johnson & Johnson Medical, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 213d
Cleared Aug 15, 1997
PRINTER INTERFACE
K970305 · Micromedical, Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 200d
Cleared Aug 15, 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348 · Siemens Medical Solutions USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 198d

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All categories 15021 DXN System, Measurement, Blood-pressure, Non-invasive 944 DQY Catheter, Percutaneous 793 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 381 LIT Catheter, Angioplasty, Peripheral, Transluminal 367 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 342 DSI Detector And Alarm, Arrhythmia 311 JOW Sleeve, Limb, Compressible 289 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275