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

    ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

    K Number: K041630 · Decision Jan 31, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    2
    Review Days
    229

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
    K Number
    K041630
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Systems Incorporated
    Date Received
    June 16, 2004
    Decision Date
    January 31, 2005
    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

    Other 510(k) clearances with the same product code (MCW), ordered by most recent decision date.

    Auryon Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Turbo-Elite Laser Atherectomy Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Rotarex Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FreedomFlow™ Orbital Circumferential Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cardiovascular Systems Incorporated

    K Number Device Name
    K133399 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM