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

    ONECATH L-CATH CATHETER SYSTEM

    K Number: K930473 · Decision Apr 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    17
    Review Days
    434

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    Basic Information

    Device Name
    ONECATH L-CATH CATHETER SYSTEM
    K Number
    K930473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Luther Medical Products, Inc.
    Date Received
    January 28, 1993
    Decision Date
    April 7, 1994
    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 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
    K942103 L-CATH CATHETER SYSTEM - PORT L-CATH
    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
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