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
14783 Cardiovascular devices
4901–4925 of 14783
Cleared Dec 21, 2011
FUKUDA DENSHI VASERA MODEL VS-1500
K112521 · Fukuda Denshi USA, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 112d
Cleared Dec 21, 2011
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
K112274 · Taidoc Technology Corporation
DXN · System, Measurement, Blood-pressure, Non-invasive · 135d
Cleared Dec 20, 2011
ELM PTA BALLON DILATATION CATHETER
K113468 · Creagh Medical, Ltd.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 28d
Cleared Dec 19, 2011
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
K112587 · Terumo Cardiovascular Systems Corp.
DWB · Pump, Blood, Cardiopulmonary Bypass, Roller Type · 104d
Cleared Dec 16, 2011
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
K110603 · I.E.M. GmbH
DXN · System, Measurement, Blood-pressure, Non-invasive · 288d
Cleared Dec 15, 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 52d
Cleared Dec 15, 2011
TEMPUSIC PATIENT MONITOR
K113105 · Remote Diagnostic Technologies , Ltd.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 56d
Cleared Dec 14, 2011
SMI CARDIOVASCULAR PACH
K112683 · Solimas Medical, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 90d
Cleared Dec 14, 2011
TERUMO ASPRIATION CATHETER
K112382 · Terumo Medical Corporation
QEZ · Aspiration Thrombectomy Catheter · 118d
Cleared Dec 14, 2011
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
K112203 · Mirador Biomedical, Inc.
DRS · Transducer, Blood-pressure, Extravascular · 135d
Cleared Dec 14, 2011
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
K111738 · Trireme Medical, Inc.
DQY · Catheter, Percutaneous · 176d
Cleared Dec 09, 2011
ATB ADVANCE PTA DILATATION CATHETER
K113300 · Cook, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 30d
Cleared Dec 09, 2011
NETKONNECT REMOTE NETWORK EXTENSION
K112637 · Nihon Kohden
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 91d
Cleared Dec 09, 2011
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
K112513 · Natec Medical , Ltd.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 101d
Cleared Dec 09, 2011
SARN CENTRIFUGAL PUMP
K112229 · Terumo Cardiovascular Systems
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 128d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO
K111830 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 164d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K111826 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 164d
Cleared Dec 07, 2011
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · Edwards Lifesciences, LLC
DXC · Clamp, Vascular · 40d
Cleared Dec 06, 2011
NOVAPORT ONE VASCULAR ACCESS CANNULA
K112565 · Novalung GmbH
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 95d
Cleared Dec 05, 2011
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
K113213 · Biosense Webster, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 34d
Cleared Dec 05, 2011
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K112845 · Microlife Intellectual Property GmbH
DXN · System, Measurement, Blood-pressure, Non-invasive · 67d
Cleared Dec 02, 2011
ANGIOJET ULTRA DVX THROMBECTOMY SET
K113428 · Medrad, Inc.
QEZ · Aspiration Thrombectomy Catheter · 11d
Cleared Dec 02, 2011
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · Medtronic, Inc.
DXS · Gauge, Pressure, Coronary, Cardiopulmonary Bypass · 30d
Cleared Dec 02, 2011
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K112559 · Medapps, Inc.
DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency · 91d
Cleared Dec 02, 2011
VOCARE MYHEALTH TABLET
K111922 · Vocare, Inc.
DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency · 149d

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All categories 14783 DXN System, Measurement, Blood-pressure, Non-invasive 924 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 698 DYB Introducer, Catheter 626 DPS Electrocardiograph 436 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 357 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 272 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 266