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

    TEMPORARY ATRIAL ELECTRODE KIT

    K Number: K760403 · Decision Aug 23, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    103
    Applicant Total
    12
    Review Days
    14

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    Basic Information

    Device Name
    TEMPORARY ATRIAL ELECTRODE KIT
    K Number
    K760403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Usci, Div. C.R. Bard, Inc.
    Date Received
    August 9, 1976
    Decision Date
    August 23, 1976
    Product Code
    DRE
    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
    DRE Dilator, Vessel, For Percutaneous Catheterization

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    Other Clearances by Usci, Div. C.R. Bard, Inc.

    K Number Device Name
    K940092 USCI INPUT INTRODUCER SET
    K884209 USCI DORROS INFUSION/PROBING CATHETER
    K771823 CATHETER, CARDIOVASCULAR
    K771982 888 ARTERIAL/VENOUS CATHETER INTRODUCER
    K772021 TRC STAINLESS STEEL SAFETY SPRING GUIDES
    K770835 PATCH FABRIC
    K770561 CATHETER,PERCUTANEOUS INTRODUC. & SHEATH
    K770236 SAUVAGE FILAMENTOUS PROSTHESES
    K770235 DEBAKEY VASCULOUR-D PROSTHESES
    K760843 PALEY TRANSPARENT MANIFOLD
    Search all 12 clearances from Usci, Div. C.R. Bard, Inc. →