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

    COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT

    K Number: K884235 · Decision Mar 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    9
    Review Days
    515

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
    K Number
    K884235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Burron Medical, Inc.
    Date Received
    October 7, 1988
    Decision Date
    March 6, 1990
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRS), ordered by most recent decision date.

    FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Compass Cast and MAP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Pressure Transducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Burron Medical, Inc.

    K Number Device Name
    K902401 CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
    K896422 BURRON AMBULATORY DRUG DELIVERY SYSTEM
    K895191 ANTI-THROMBOGENIC COATING FOR CATHETERS
    K895192 SPINOCAN(R) CONTINUOUS SPINAL TRAY
    K884183 BURRON TEFLON-COATED GUIDEWIRE
    K882106 PERFUSOR M SYRINGE PUMP
    K882107 PERFUSOR SECURA SYRINGE PUMP
    K881342 IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM