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

    PICC LINE KIT

    K Number: K952256 · Decision Jul 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    13
    Review Days
    77

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    Basic Information

    Device Name
    PICC LINE KIT
    K Number
    K952256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medi-Flex Hospital Products, Inc.
    Date Received
    May 15, 1995
    Decision Date
    July 31, 1995
    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 Medi-Flex Hospital Products, Inc.

    K Number Device Name
    K970441 K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
    K962740 DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
    K952201 PORT-A-CATH ACCESS KIT
    K952416 TRACHEOSTOMY CARE 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
    Search all 13 clearances from Medi-Flex Hospital Products, Inc. →