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

    VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT

    K Number: K861563 · Decision Aug 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    13
    Review Days
    124

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    Basic Information

    Device Name
    VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT
    K Number
    K861563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Vitaphore Corp.
    Date Received
    April 25, 1986
    Decision Date
    August 27, 1986
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Vitaphore Corp.

    K Number Device Name
    K914579 SILVER FOAM WOUND DRESSING
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    K902558 COLLAGEN SHIELD FOR ACUTE CARE
    K891993 COLLAGEN NEUROSPONGE
    K896455 VITACHOICE WOUND DRESSING
    K896046 VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
    K895993 VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE
    K890435 VITAACCESS CATHETER INTRODUCER KIT
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