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

    I.V. START KIT

    K Number: K931729 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    22
    Review Days
    321

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    Basic Information

    Device Name
    I.V. START KIT
    K Number
    K931729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Carapace, Inc.
    Date Received
    April 7, 1993
    Decision Date
    February 22, 1994
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Carapace, Inc.

    K Number Device Name
    K931722 CARAPACE LABOR AND DELIVERY SETS
    K931822 CARAPACE PELVIC EXAM TRAYS
    K931820 CARAPACE STILLWATER BOWL SET
    K931669 CARAPACE DEBRIDEMENT KITS
    K931760 CARAPACE PACKING GAUZE TRAYS
    K932653 SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
    K931758 CARAPACE WOUND DRESSING KITS & LACERATION TRAYS
    K931819 CARAPACE SUTURE REMOVAL TRAYS
    K931670 CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS
    K931759 CARAPACE STERILE GAUZE TRAYS
    Search all 22 clearances from Carapace, Inc. →