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

    CSTAT, MODELS 09-0014-01 AND 09-0014-02

    K Number: K032125 · Decision Feb 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    9
    Review Days
    214

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    Basic Information

    Device Name
    CSTAT, MODELS 09-0014-01 AND 09-0014-02
    K Number
    K032125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Control Systems, Inc.
    Date Received
    July 10, 2003
    Decision Date
    February 9, 2004
    Product Code
    DXC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXC Clamp, Vascular

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    Other Clearances by Vascular Control Systems, Inc.

    K Number Device Name
    K060573 BURBANK TENACULUM
    K052209 VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
    K031812 TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
    K031358 TRANSVAGINAL DOPPLER PROBE
    K030078 BURBANK TENACULUM, MODEL 09-0011-01
    K023154 VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
    K023024 TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
    K011863 VCS-A SERIES CLAMP