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

    FlexCath Select Steerable Sheath (10 French)

    K Number: K142684 · Decision Nov 6, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    FlexCath Select Steerable Sheath (10 French)
    K Number
    K142684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Cryocath, LP
    Date Received
    September 19, 2014
    Decision Date
    November 6, 2014
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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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
    K123591 FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
    K102176 FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10