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

    VascuEase IC-1200-WH

    K Number: K180248 · Decision Aug 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    341
    Applicant Total
    4
    Review Days
    190

    Basic Information

    Device Name
    VascuEase IC-1200-WH
    K Number
    K180248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio Compression Systems, Inc.
    Date Received
    January 29, 2018
    Decision Date
    August 7, 2018
    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 Bio Compression Systems, Inc.

    K Number Device Name
    K213533 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
    K210417 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
    K171793 Sequential Circulator SC-2004FC-OC