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

    ACKRAD TDI SET

    K Number: K864818 · Decision Apr 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    42
    Review Days
    121

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    Basic Information

    Device Name
    ACKRAD TDI SET
    K Number
    K864818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ackrad Laboratories
    Date Received
    December 9, 1986
    Decision Date
    April 9, 1987
    Product Code
    KRB
    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
    KRB Probe, Thermodilution

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    Other Clearances by Ackrad Laboratories

    K Number Device Name
    K021272 SIB CATHETER, MODEL 61-7005
    K020954 H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
    K020951 H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
    K970492 INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
    K961752 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
    K940176 ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
    K952542 ACKRAD ESOPHAGEAL BALLOON CATHETER SET
    K953034 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
    K915813 ACKRAD ERCP CONTRAST DELIVERY SET
    K904499 NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
    Search all 42 clearances from Ackrad Laboratories →