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

    TRULINE INFUSION CATHETERS

    K Number: K011937 · Decision Aug 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    51
    Review Days
    68

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    Basic Information

    Device Name
    TRULINE INFUSION CATHETERS
    K Number
    K011937
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc.
    Date Received
    June 21, 2001
    Decision Date
    August 28, 2001
    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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    Other Clearances by Micro Therapeutics, Inc.

    K Number Device Name
    K113289 ORION MICRO CATHETER
    K113454 14 WIRE STANDARD, 14 WIRE LS
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    K090046 CONCERTO DETACHABLE COIL SYSTEM
    K081465 AXIUM DETACHABLE COIL SYSTEM
    K060747 FX DETACHABLE COIL SYSTEM
    K060625 NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
    K051990 ECHELON MICRO CATHETER
    K051560 NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
    K051425 NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
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