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

    V.A.D. ACCESS KIT

    K Number: K932010 · Decision Feb 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    16
    Review Days
    286

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    Basic Information

    Device Name
    V.A.D. ACCESS KIT
    K Number
    K932010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinipad Corp.
    Date Received
    April 23, 1993
    Decision Date
    February 3, 1994
    Product Code
    LJT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Clinipad Corp.

    K Number Device Name
    K931560 CARDIAC CATHETERIZATION TRAY
    K931668 PICC INSERTION TRAY
    K932071 I.V. START KIT
    K932036 LACERATION TRAY
    K932016 TRACHEOSTOMY CARE TRAY
    K862562 PUNCH BIOPSY KIT
    K862563 TRACHEOSTOMY CLEANSING SOLUTION
    K833075 WET DRESSING KIT
    K833432 CATHETER INSERTION KIT
    K830476 OR PREP KIT
    Search all 16 clearances from Clinipad Corp. →