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

    L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER

    K Number: K974543 · Decision Feb 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    17
    Review Days
    69

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    Basic Information

    Device Name
    L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
    K Number
    K974543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luther Medical Products, Inc.
    Date Received
    December 3, 1997
    Decision Date
    February 10, 1998
    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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    K980090 ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
    K940198 L-CATH CONNECTOR ASSEMBLY
    K942103 L-CATH CATHETER SYSTEM - PORT L-CATH
    K930473 ONECATH L-CATH CATHETER SYSTEM
    K925236 L CATH(R) CATHETER SYSTEM
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    K925979 DUAL LUMEN L-CATH CATHETER SYSTEM
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    K924562 CATHETER INTRODUCER
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