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
14962 Cardiovascular devices
7926–7950 of 14962
Cleared Oct 29, 2002
EXPORT ASPIRATION CATHETER
K023303 · Medtronic Vascular
NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection · 26d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300 · Guidant Corp.
DQX · Wire, Guide, Catheter · 25d
Cleared Oct 25, 2002
MEDCOMP VASCU-SHEATH INTRODUCER SET
K022513 · Medcomp
DYB · Introducer, Catheter · 87d
Cleared Oct 24, 2002
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 8d
Cleared Oct 22, 2002
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
K022450 · Dideco S.P.A.
DTZ · Oxygenator, Cardiopulmonary Bypass · 88d
Cleared Oct 18, 2002
AROX 45-JBP
K023099 · Biotronik, Inc.
DTB · Permanent Pacemaker Electrode · 30d
Cleared Oct 18, 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · Cordis Corp.
DTK · Filter, Intravascular, Cardiovascular · 29d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K022357 · Boston Scientific, Target
DQX · Wire, Guide, Catheter · 89d
Cleared Oct 11, 2002
REPROCESSED IMAGING CATHETERS
K012537 · Sterilmed, Inc.
OWQ · Reprocessed Intravascular Ultrasound Catheter · 430d
Cleared Oct 11, 2002
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117 · Merit Medical Systems, Inc.
DRC · Trocar · 102d
Cleared Oct 10, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K022316 · Vanguard Medical Concepts, Inc.
NLH · Catheter, Recording, Electrode, Reprocessed · 85d
Cleared Oct 09, 2002
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
K022238 · Medtronic Vascular
DWS · Instruments, Surgical, Cardiovascular · 90d
Cleared Oct 03, 2002
RADIANALYZER, MODEL 12710
K022188 · Radi Medical Systems AB
DQK · Computer, Diagnostic, Programmable · 90d
Cleared Oct 03, 2002
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485 · Datex-Ohmeda
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 66d
Cleared Oct 01, 2002
UNITY NETWORK ID
K021454 · General Electric Medical Systems Information Techn
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 148d
Cleared Oct 01, 2002
QIVA
K021495 · Pie Medical Imaging BV
DQK · Computer, Diagnostic, Programmable · 145d
Cleared Oct 01, 2002
LIVESIRE ELECTROPHYSIOLOGY CATHETER
K022380 · St Jude Medical
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 71d
Cleared Sep 27, 2002
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
K022115 · Terumo Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 88d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · Cook, Inc.
DQY · Catheter, Percutaneous · 56d
Cleared Sep 25, 2002
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
K022889 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 26d
Cleared Sep 24, 2002
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · Radi Medical Systems AB
DXO · Transducer, Pressure, Catheter Tip · 81d
Cleared Sep 23, 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
K022138 · Spectranetics Corp.
DQY · Catheter, Percutaneous · 83d
Cleared Sep 20, 2002
CHASE CARDIOVASCULAR PATCH KIT
K022093 · Chase Medical, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 85d
Cleared Sep 19, 2002
DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
K022075 · Cp Medical
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 85d
Cleared Sep 19, 2002
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · St. Jude Medical, Inc.
KRH · Ring, Annuloplasty · 59d

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All categories 14962 DXN System, Measurement, Blood-pressure, Non-invasive 939 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 404 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 338 DSI Detector And Alarm, Arrhythmia 310 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275