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

    TRACHEOSTOMY CARE KIT

    K Number: K952416 · Decision Aug 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    13
    Review Days
    78

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    Basic Information

    Device Name
    TRACHEOSTOMY CARE KIT
    K Number
    K952416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Medi-Flex Hospital Products, Inc.
    Date Received
    May 23, 1995
    Decision Date
    August 9, 1995
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

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    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

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    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

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    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

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    Other Clearances by Medi-Flex Hospital Products, Inc.

    K Number Device Name
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    K952201 PORT-A-CATH ACCESS KIT
    K952256 PICC LINE KIT
    K952007 ADHEROL SEPP APPLICATOR
    K934790 SEPP ADHESIVE REMOVER
    K920399 COMPOUND BENZOIN TINCTURE USP FREPP
    K923516 COMPOUND BENZOIN TINCTURE USP SEPP
    K930196 CEPTI-SEAL I.V. PREP KIT
    K921347 CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
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