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

    PEDIA-THOR THORACOSTOMY KIT

    K Number: K913540 · Decision Apr 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    12
    Review Days
    244

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    Basic Information

    Device Name
    PEDIA-THOR THORACOSTOMY KIT
    K Number
    K913540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intl. Medical Devices , Ltd.
    Date Received
    August 9, 1991
    Decision Date
    April 9, 1992
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Intl. Medical Devices , Ltd.

    K Number Device Name
    K913541 NEO-THOR THORACOSTOMY KIT
    K913539 THORACIC CATHTER STYLET
    K913542 THORACIC CATHETER WITH GUIDE
    K913543 THORACIC CATHETER STYLET
    K862909 RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
    K850398 NU-CATH EMERGENCY KIT
    K843785 WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
    K842666 NU-THOR THORACOSTOMY KIT
    K840925 PEDIA-TRAKE CRICOTHYROTOMY KIT
    K820778 RESPIRATION MONITOR 1000
    Search all 12 clearances from Intl. Medical Devices , Ltd. →