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

    ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS

    K Number: K950855 · Decision May 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    3
    Review Days
    92

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    Basic Information

    Device Name
    ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS
    K Number
    K950855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adam Spence Corp.
    Date Received
    February 27, 1995
    Decision Date
    May 30, 1995
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Adam Spence Corp.

    K Number Device Name
    K983940 EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
    K955111 MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER