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

    L-CATH CATHETER SYSTEM - PORT L-CATH

    K Number: K942103 · Decision Jul 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    17
    Review Days
    85

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    Basic Information

    Device Name
    L-CATH CATHETER SYSTEM - PORT L-CATH
    K Number
    K942103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luther Medical Products, Inc.
    Date Received
    May 2, 1994
    Decision Date
    July 26, 1994
    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 Luther Medical Products, Inc.

    K Number Device Name
    K982797 BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
    K980090 ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
    K974543 L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
    K940198 L-CATH CONNECTOR ASSEMBLY
    K930473 ONECATH L-CATH CATHETER SYSTEM
    K925236 L CATH(R) CATHETER SYSTEM
    K920755 L-CATH PEEL AWAY SYSTEM CATHETER
    K925979 DUAL LUMEN L-CATH CATHETER SYSTEM
    K924968 L-CATH PEEL-AWAY CATHETER SYSTEM
    K924562 CATHETER INTRODUCER
    Search all 17 clearances from Luther Medical Products, Inc. →