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510(k) Data Aggregation

    K Number
    K060573
    Device Name
    BURBANK TENACULUM
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2006-04-21

    (46 days)

    Product Code
    HDC, DXC
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures. This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.
    Device Description
    The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place. A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.
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    K Number
    K052209
    Device Name
    VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2005-09-06

    (22 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCS Doppler Transceiver is designed for the evaluation of blood flow in uterine arteries.
    Device Description
    The VCS Doppler Transceiver is a battery powered pulsed Doppler ultrasound system designed for the evaluation of blood flow in vessels. An 8 MHz Doppler device, which plugs into the transceiver unit, emits a pulsed ultrasonic signal. A varying audible signal is produced when the device is placed upon a vessel within which there is flow. The frequency (i.e., pitch) of the signal is proportional to the blood velocity within the vessel. Distinctive tonal patterns are produced which are indicative of the flow pattern in terms of velocity vs. time. The volume of the tone may be adjusted by the means of a control on the transceiver. Rechargeable batteries power the transceiver. An 8 MHz transmitter in the transceiver periodically drives the ultrasonic transmitting sensor located at the tip of the device. The ultrasonic waves generated by the sensor travel through the tissue just under the device tip in a fairly narrow beam. The waves are then reflected back towards the device whenever they encounter a boundary between tissues of different densities. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the re-turning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
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    K Number
    K032125
    Device Name
    CSTAT, MODELS 09-0014-01 AND 09-0014-02
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2004-02-09

    (214 days)

    Product Code
    DXC, ITX
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cstat is intended for detection and temporary occlusion of blood vessels during vascular surgical procedures.
    Device Description
    The Cstat is a ring-handled instrument with integrated Doppler sensor, which allows for blood flow sensing of blood vessels by connecting to a commercially available portable transceiver box. The Cstat is manufactured from nylon and polycarbonate.
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    K Number
    K031812
    Device Name
    TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2003-12-12

    (183 days)

    Product Code
    DXC, HHM, ITX, JAF, MDC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transvaginal Doppler Clamp is intended for bilateral detection and temporary occlusion of the uterine arteries during conservative gynecological surgery such as laparoscopic myomectomy.
    Device Description
    Transvaginal Doppler Clamp
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    K Number
    K031358
    Device Name
    TRANSVAGINAL DOPPLER PROBE
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2003-05-09

    (9 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
    Device Description
    The Transvaginal Doppler Probe is a ring-handled instrument with integrated Doppler sensors, which allow for bilateral blood flow sensing of the uterine blood vessels by connecting to a commercially available portable transceiver box. The Transvaginal Doppler Probe is manufactured from stainless steel.
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    K Number
    K030078
    Device Name
    BURBANK TENACULUM, MODEL 09-0011-01
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2003-01-24

    (15 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.
    Device Description
    The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.
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    K Number
    K023154
    Device Name
    VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2002-12-20

    (88 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCS-A Series Clamp is intended for use in the temporary occlusion of blood vessels during vascular surgical procedures.
    Device Description
    The VCS-A Series Clamp is a ring-handled instrument with integrated Doppler sensor, which allows temporary occlusion of blood vessels. The Doppler sensor allows audible sensing of blood flow by connecting to a commercially available portable transceiver box. The VCS-A series Clamp is manufactured from stainless steel.
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    K Number
    K023024
    Device Name
    TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2002-09-26

    (15 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
    Device Description
    The Transvaginal Doppler Probe is a ring-handled instrument with integrated Doppler sensors, which allow for bilateral blood flow sensing of the uterine blood vessels by connecting to a commercially available portable transceiver box. The Transvaginal Doppler Probe is manufactured from stainless steel.
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    K Number
    K011863
    Device Name
    VCS-A SERIES CLAMP
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2002-02-15

    (246 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR CONTROL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCS-A Series Clamp is indicated for use in the temporary occlusion of blood vessels during vascular surgical procedures.
    Device Description
    The VCS-A Series Clamp with Ultrasound Doppler is a ring handled mechanical surgical instrument with a ratchet closure to adjust the tension required to occlude the target vessel. The Clamp has an integrated Doppler probe, which allows for blood flow monitoring by using a conventional portable Doppler Ultrasound unit. The VCS-A Series Clamp is made of surgical grade stainless steel and is available in various sizes. The clamp is a sterile, single use device. The method of sterilization will be Gamma Radiation with a SAL of 106.
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