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
14847 Cardiovascular devices
Cleared
Jan 13, 2009
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
PDU
Catheter For Crossing Total Occlusions
22d
Cleared
Jan 12, 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
DQX
Wire, Guide, Catheter
81d
Cleared
Jan 12, 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
DXT
Injector And Syringe, Angiographic
104d
Cleared
Jan 12, 2009
VITAL SIGNS MONITOR, MODEL: MD500B
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
111d
Cleared
Jan 12, 2009
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
DSP
System, Balloon, Intra-aortic And Control
115d
Cleared
Jan 09, 2009
CONFIDANT, MODEL 2.6
DRG
Transmitters And Receivers, Physiological Signal, Radiofrequency
58d
Cleared
Jan 07, 2009
CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
DXN
System, Measurement, Blood-pressure, Non-invasive
184d
Cleared
Jan 07, 2009
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
349d
Cleared
Jan 06, 2009
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
249d
Cleared
Dec 30, 2008
MERIT MICROCATHETER
KRA
Catheter, Continuous Flush
113d
Cleared
Dec 30, 2008
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021
OCL
Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
147d
Cleared
Dec 29, 2008
MORTARA ELI 350 ELECTROCARDIOGRAPH
DPS
Electrocardiograph
88d
Cleared
Dec 29, 2008
VICOR PD2I ANALYZER, VERSION 2.1
DPS
Electrocardiograph
104d
Cleared
Dec 24, 2008
CONQUEST PTA BALLOON DILATATION CATHETER
DQY
Catheter, Percutaneous
14d
Cleared
Dec 24, 2008
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
DRL
Tester, Defibrillator
41d
Cleared
Dec 24, 2008
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
48d
Cleared
Dec 24, 2008
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
KRD
Device, Vascular, For Promoting Embolization
68d
Cleared
Dec 19, 2008
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
DXQ
Blood Pressure Cuff
100d
Cleared
Dec 18, 2008
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
38d
Cleared
Dec 17, 2008
HEARTSUITE HEMODYNAMICS 7.10
DQK
Computer, Diagnostic, Programmable
117d
Cleared
Dec 17, 2008
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
124d
Cleared
Dec 17, 2008
BARD PTFE (TEFLON) COATED GUIDE WIRES
DQX
Wire, Guide, Catheter
146d
Cleared
Dec 17, 2008
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
DXN
System, Measurement, Blood-pressure, Non-invasive
202d
Cleared
Dec 15, 2008
HEARTRAK SMART ECAT
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
17d
Cleared
Dec 15, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
DYB
Introducer, Catheter
27d
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