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

    DEVON CIRONA 6200 DVT

    K Number: K141578 · Decision Jun 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    14

    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
    DEVON CIRONA 6200 DVT
    K Number
    K141578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Devon Medical
    Date Received
    June 13, 2014
    Decision Date
    June 27, 2014
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

    Similar 510(k) Clearances

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

    Compression Therapy Device (LGT-2202DVT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NanoPress 760A-BT (760A-BT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bio Arterial Deluxe (IC-BAP-DX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sequential Compression System (SCD600)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PlasmaFlow X Compression Sleeve Device (XPF0001)

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

    Other Clearances by Devon Medical

    K Number Device Name
    K132252 EXTRICARE 100CC/ 250CC/ 400CC CANISTERS