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

    FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)

    K Number: K123591 · Decision Dec 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
    K Number
    K123591
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Cryocath, LP
    Date Received
    November 21, 2012
    Decision Date
    December 27, 2012
    Product Code
    DRA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRA Catheter, Steerable

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    Other Clearances by Medtronic Cryocath, LP

    K Number Device Name
    K202620 FlexCath Advance Steerable Sheath and Dilator
    K183174 FlexCath Advance Steerable Sheath and Dilator
    K163268 FlexCath Select Steerable Shealth and Dilator
    K142684 FlexCath Select Steerable Sheath (10 French)
    K102176 FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10