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

    SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES

    K Number: K122628 · Decision Sep 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    4
    Review Days
    9

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    Basic Information

    Device Name
    SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
    K Number
    K122628
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datascope Corp., Cardiac Assist Division
    Date Received
    August 28, 2012
    Decision Date
    September 6, 2012
    Product Code
    DSP
    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
    DSP System, Balloon, Intra-Aortic And Control

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    Other Clearances by Datascope Corp., Cardiac Assist Division

    K Number Device Name
    K122405 AIR-BAND RADIAL COMPRESSION DEVICE
    K120868 MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
    K091449 DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02