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

    P51 ANGIOPLASTY PRESSURE TRANSDUCER

    K Number: K813331 · Decision Dec 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    3
    Review Days
    35

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    Basic Information

    Device Name
    P51 ANGIOPLASTY PRESSURE TRANSDUCER
    K Number
    K813331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Konigsberg Instruments, Inc.
    Date Received
    November 24, 1981
    Decision Date
    December 29, 1981
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Konigsberg Instruments, Inc.

    K Number Device Name
    K980980 MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
    K811083 ESOPHAGEAL MOTILITY PROBE