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

    PRO-PICC WITH VALVE TECHNOLOGY

    K Number: K141633 · Decision Sep 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    63
    Review Days
    103

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    Basic Information

    Device Name
    PRO-PICC WITH VALVE TECHNOLOGY
    K Number
    K141633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc.
    Date Received
    June 18, 2014
    Decision Date
    September 29, 2014
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Medical Components, Inc.

    K Number Device Name
    K250836 14F Duo-Flow® Side X Side Double Lumen Catheter
    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
    K120281 DIGNITY POWER INJECTABLE TITANIUM PORT
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