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

    FreedomFlow Orbital Circumferential Atherectomy System

    K Number: K231538 · Decision Sep 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    5
    Review Days
    120

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    Basic Information

    Device Name
    FreedomFlow Orbital Circumferential Atherectomy System
    K Number
    K231538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardio Flow Inc.,
    Date Received
    May 30, 2023
    Decision Date
    September 27, 2023
    Product Code
    MCW
    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
    MCW Catheter, Peripheral, Atherectomy

    Similar 510(k) Clearances

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    View all

    Other Clearances by Cardio Flow Inc.,

    K Number Device Name
    K250723 FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
    K242947 FreedomFlow™ Orbital Circumferential Atherectomy System
    K233483 FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
    K213834 Cardio Flow Peripheral Guide Wire