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

    VTI DISPOSABLE PRESSURE DISPLAY SET

    K Number: K944764 · Decision Dec 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    11
    Review Days
    91

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    Basic Information

    Device Name
    VTI DISPOSABLE PRESSURE DISPLAY SET
    K Number
    K944764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Technology Incorporated
    Date Received
    September 27, 1994
    Decision Date
    December 27, 1994
    Product Code
    DXS
    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
    DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

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    Other Clearances by Vascular Technology Incorporated

    K Number Device Name
    K082870 VTI INTRAOPERATIVE DOPPLER SYSTEMS
    K031091 VTI 20 MHZ GATED DOPPLER
    K002990 VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
    K922738 VTI OXYGEN ANALYZER
    K890058 VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
    K883960 GIPHY MONITOR
    K864583 CARDIAC PERFORMANCE MONITOR
    K862114 KHURI REGIONAL TISSUE PH MONITOR
    K862113 NO. 100352 GALVANIC OXYGEN SENSOR
    K852275 VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR
    Search all 11 clearances from Vascular Technology Incorporated →