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

    PALEY TRANSPARENT MANIFOLD

    K Number: K760843 · Decision Nov 12, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    150
    Same Product Code
    137
    Applicant Total
    12
    Review Days
    29

    Basic Information

    Device Name
    PALEY TRANSPARENT MANIFOLD
    K Number
    K760843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    USCI, DIV. C.R. BARD, INC.
    Date Received
    October 14, 1976
    Decision Date
    November 12, 1976
    Product Code
    DTL
    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
    DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Y-Connector Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Attachable Cath Lab Hemostasis Valve

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Passage Hemostasis Valve

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROTATING ADAPTERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLIGN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE

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

    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
    K760403 TEMPORARY ATRIAL ELECTRODE KIT
    Search all 12 clearances from USCI, DIV. C.R. BARD, INC. →