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

    VPS Rhythm DLX Device with TipTracker Technology

    K Number: K220363 · Decision Aug 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    4
    Review Days
    195

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    Basic Information

    Device Name
    VPS Rhythm DLX Device with TipTracker Technology
    K Number
    K220363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International, LLC (A subsidiary of Teleflex, Inc.)
    Date Received
    February 8, 2022
    Decision Date
    August 22, 2022
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Arrow International, LLC (A subsidiary of Teleflex, Inc.)

    K Number Device Name
    K243599 Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
    K242281 Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
    K220280 Arrow Stiffening Stylet