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510(k) Data Aggregation

    K Number
    K200439
    Device Name
    Velano ExT Extension Set
    Manufacturer
    Velano Vascular
    Date Cleared
    2021-02-23

    (365 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.
    Device Description
    The Velano ExT™ Extension Set is a sterile, single use, non-pyrogenic intravenous administration extension set comprised of an approximate 5" inch tube bonded to a T-connection port on one end and a female luer on the other end with a clamp in between. The T-connection port has a swabable, needle-free port on one side and a locking male luer on the other side. The device contains and integrated stabilizer under the swabable needle-free port. This component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano ExT™ Extension Set is compatible with Velano Vascular PIVOT™ devices.
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    K Number
    K193569
    Device Name
    PIVO(TM)
    Manufacturer
    Velano Vascular
    Date Cleared
    2020-01-21

    (29 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.
    Device Description
    The PIVO™ device is a sterile, single use device. It is a needlefree blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.
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    K Number
    K190604
    Device Name
    PIVO
    Manufacturer
    Velano Vascular
    Date Cleared
    2019-05-13

    (66 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.
    Device Description
    The PIVO™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.
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    K Number
    K182897
    Device Name
    Velano Vascular Q2 Extension Set
    Manufacturer
    Velano Vascular
    Date Cleared
    2019-03-26

    (161 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. Non Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
    Device Description
    Sterile, single use non-pyrogenic intravenous administration extension set comprised of 5.75 inch tubing bonded to a male luer on one end and a T-connector on the other end with a clamp in between. The T-connector has a female luer on one side and a swabable, needle-free port on the other side. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano Vascular Q2® Extension Set is compatible with PIVO™ devices.
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    K Number
    K163508
    Device Name
    PIVO
    Manufacturer
    Velano Vascular
    Date Cleared
    2017-02-09

    (57 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.
    Device Description
    The PIVO™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes compatible with 20 and 22 gage PIV's, respectively.
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    K Number
    K152924
    Device Name
    TIVA¿
    Manufacturer
    VELANO VASCULAR
    Date Cleared
    2016-01-07

    (94 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    VELANO VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TIVA™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.
    Device Description
    The TIVA™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes compatible with 20 and 22 gauge PIV's, respectively.
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    K Number
    K142946
    Device Name
    TIVA
    Manufacturer
    Velano Vascular, Inc.
    Date Cleared
    2015-01-08

    (90 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TIVA™ device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or a syringe.
    Device Description
    The TIVATM device is a sterile, single use device. It is a needle-free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes 20 and 22 gauge.
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