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
15019 Cardiovascular devices
9301–9325 of 15019
Cleared Nov 19, 1997
LMI IRRIGATION CATHETER (IGR)
K972623 · Lucas Medical, Inc.
DXE · Catheter, Embolectomy · 128d
Cleared Nov 19, 1997
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp
KRA · Catheter, Continuous Flush · 56d
Cleared Nov 18, 1997
SAFPACE SYSTEM
K955829 · B.Braun Medical, Inc.
LDF · Electrode, Pacemaker, Temporary · 693d
Cleared Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · Cordis Corp.
DQO · Catheter, Intravascular, Diagnostic · 70d
Cleared Nov 17, 1997
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING
K970938 · Biocompatibles Cardiovascular, Inc.
DQX · Wire, Guide, Catheter · 249d
Cleared Nov 14, 1997
IBC CARDIAC SUCTION WARD
K963756 · International Biophysics Corp.
DTS · Sucker, Cardiotomy Return, Cardiopulmonary Bypass · 423d
Cleared Nov 13, 1997
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
K971868 · Marquette Electronics, Inc.
MSX · System, Network And Communication, Physiological Monitors · 177d
Cleared Nov 12, 1997
BCI MODEL 6004 NIBP MONITOR (6004)
K970801 · Bci Intl., Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 253d
Cleared Nov 12, 1997
HEART ACCESS PLUS CARDIAC EVENT RECORDER
K973141 · Paceart, Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 83d
Cleared Nov 07, 1997
ACUITY CENTRAL STATION
K972121 · Protocol Systems, Inc.
MLD · Monitor, St Segment With Alarm · 155d
Cleared Nov 06, 1997
LIFEPAK 300
K962359 · Physio-Control Corp.
MKJ · Automated External Defibrillators (non-wearable) · 505d
Cleared Nov 06, 1997
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH
K962473 · Data Critical Corporation
MSX · System, Network And Communication, Physiological Monitors · 499d
Cleared Nov 06, 1997
QUEST VESSEL CATHETER
K971928 · Quest Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 163d
Cleared Nov 06, 1997
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962 · 3M Company
DRY · Monitor, Blood-gas, On-line, Cardiopulmonary Bypass · 87d
Cleared Nov 06, 1997
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · Datascope Corp.
DYB · Introducer, Catheter · 85d
Cleared Nov 04, 1997
TRINITY DVT SYSTEM
K963957 · Delphi Consulting Group
JOW · Sleeve, Limb, Compressible · 398d
Cleared Nov 04, 1997
PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
K970853 · Cardima, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 242d
Cleared Nov 04, 1997
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · Cordis Neurovascular, Inc.
KRA · Catheter, Continuous Flush · 120d
Cleared Nov 03, 1997
THEROX INFUSION GUIDEWIRES
K971719 · Therox, Inc.
DQX · Wire, Guide, Catheter · 178d
Cleared Nov 03, 1997
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
K972944 · Medtronics Interventional Vascular
DQX · Wire, Guide, Catheter · 84d
Cleared Oct 31, 1997
GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS
K963368 · Glycar, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 430d
Cleared Oct 31, 1997
GLYCAR PERICARDIAL PATCH
K963967 · Glycar, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 394d
Cleared Oct 31, 1997
RETRIEVER II
K964210 · Target Therapeutics
DQO · Catheter, Intravascular, Diagnostic · 374d
Cleared Oct 30, 1997
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
K970638 · Cardiothoracic Systems, Inc.
DXC · Clamp, Vascular · 252d
Cleared Oct 28, 1997
CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
K970264 · Cordis Webster, Inc.
DYB · Introducer, Catheter · 278d

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All categories 15019 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 380 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