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

    SCD EXPRESS PORTABLE COMPRESSION SYSTEM

    K Number: K040511 · Decision Jun 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    4
    Review Days
    122

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    Basic Information

    Device Name
    SCD EXPRESS PORTABLE COMPRESSION SYSTEM
    K Number
    K040511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyco Healthcare/Kendall
    Date Received
    February 27, 2004
    Decision Date
    June 28, 2004
    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 Tyco Healthcare/Kendall

    K Number Device Name
    K060339 KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
    K051805 KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
    K040196 KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS