BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    USCI CARDIOVASCULAR CATHETER

    K Number: K810412 · Decision Mar 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    497
    Applicant Total
    566
    Review Days
    15

    Basic Information

    Device Name
    USCI CARDIOVASCULAR CATHETER
    K Number
    K810412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    C.R. BARD, INC.
    Date Received
    February 18, 1981
    Decision Date
    March 5, 1981
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.

    Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    pNOVUS 21 Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Impress Angiographic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zoom 6F Insert Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Soldier Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFINITI™ Ambi Angiographic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by C.R. BARD, INC.

    K Number Device Name
    K163001 PowerFlow Apheresis I.V. Port
    K162769 Pinpoint GT Introducer Needle
    K162443 PowerPICC Provena Catheters
    K162377 PowerGlide Pro Midline Catheter
    K153280 PowerGlide Pro Midline Catheter
    K153359 BardPort®, SlimPort®, and X-Port® Implanted Ports
    K153236 Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
    K160866 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
    K141531 POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
    K150345 Magic3 Go Intermittent Urinary Catheter
    Search all 566 clearances from C.R. BARD, INC. →