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

    REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING

    K Number: K935184 · Decision Feb 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    23
    Review Days
    472

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    Basic Information

    Device Name
    REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
    K Number
    K935184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    St. Jude Medical, Inc.
    Date Received
    October 26, 1993
    Decision Date
    February 10, 1995
    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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