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

    REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP

    K Number: K021528 · Decision Aug 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    6
    Review Days
    103

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    Basic Information

    Device Name
    REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
    K Number
    K021528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adven Medical
    Date Received
    May 10, 2002
    Decision Date
    August 21, 2002
    Product Code
    JOW
    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
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Adven Medical

    K Number Device Name
    K013987 REPROCESSED DISPOSABLE TROCARS
    K012675 REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
    K012676 REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
    K012694 REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
    K940501 RE-SHARPENABLE SAW BLADES