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

    SAM JUNCTIONAL TOURNIQUET

    K Number: K131561 · Decision Jul 24, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    4
    Review Days
    55

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    Basic Information

    Device Name
    SAM JUNCTIONAL TOURNIQUET
    K Number
    K131561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sam Medical Products
    Date Received
    May 30, 2013
    Decision Date
    July 24, 2013
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by Sam Medical Products

    K Number Device Name
    K133121 CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
    K123694 SAM JUNCTIONAL TOURNIQUET
    K102403 SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL