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

    DIGNITY POWER INJECTABLE TITANIUM PORT

    K Number: K120281 · Decision Sep 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    63
    Review Days
    230

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    Basic Information

    Device Name
    DIGNITY POWER INJECTABLE TITANIUM PORT
    K Number
    K120281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc.
    Date Received
    January 31, 2012
    Decision Date
    September 17, 2012
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Medical Components, Inc.

    K Number Device Name
    K250836 14F Duo-Flow® Side X Side Double Lumen Catheter
    K141633 PRO-PICC WITH VALVE TECHNOLOGY
    K132880 MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
    K131687 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
    K130687 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
    K130923 5F DIGNITY CT TITANIUM PORT
    K124046 VALVED TEARAWAY INTRODUCER GENERATION II
    K123617 3F PRO-PICC
    K122423 VASU-PICC
    K121848 SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
    Search all 63 clearances from Medical Components, Inc. →