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

    MILLAR MIKRO-TIP CATHETER PHONOTRANS

    K Number: K802830 · Decision Dec 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    18
    Review Days
    30

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    Basic Information

    Device Name
    MILLAR MIKRO-TIP CATHETER PHONOTRANS
    K Number
    K802830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1270
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Millar Instruments, Inc.
    Date Received
    November 10, 1980
    Decision Date
    December 10, 1980
    Product Code
    DXW
    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
    DXW System, Phonocatheter, Intracavitary

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    Other Clearances by Millar Instruments, Inc.

    K Number Device Name
    K112323 CARDIA-CATH
    K093111 MIKRO-CATH, MODEL 825-0101
    K013205 MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
    K993694 MIKRO-TIP ANGIOGRAPHIC CATHETER
    K952773 MIKRO-TIP ANGIOGRAPHIC CATHETER
    K935166 FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER
    K915775 MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN
    K896264 MILLAR MIKRO-TIP DOPPLER CATHETER
    K895721 MILLAR MIKRO-TIP PULSE TRANSDUCER
    K883651 MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER
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