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510(k) Data Aggregation

    K Number
    K211802
    Device Name
    GoBack Crossing Catheter
    Date Cleared
    2022-03-01

    (264 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Upstream Peripheral Technologies, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.
    Device Description
    The Upstream GoBack Crossing Catheter is a sterile, single-use, single lumen crossing catheter. The Upstream GoBack Crossing Catheter is intended for use with 0.014" coated or noncoated guidewires. The effective length of the GoBack Crossing Catheter is 80 cm or 120 cm with an outer diameter of either 0.96 mm (2.9 Fr) or 1.4 mm. (4.0 Fr). The GoBack Crossing Catheter is made from three lavers; a reinforced polyimide shaft with stainless steel distal tip (in the 2.9 Fr device) or stainless steel and Nylon 12 distal tip (in the 4.0 Fr device), nitinol hypotube, and PTFE polymer sleeve over the nitinol hypotube inside the shaft. The nitinol hypotube has a pre-shaped curved lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube / needle can move at limited displacement inside the shaft by moving a sliding knob in the catheter handle. The nitinol tube (with the PTFE sleeve) and the polyimide shaft may rotate together using a rotation knob on the catheter handle.
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    K Number
    K182937
    Device Name
    Upstream GoBack Crossing Catheter
    Date Cleared
    2019-05-23

    (213 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Upstream Peripheral Technologies, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.
    Device Description
    The Upstream GoBack Crossing Catheter is a sterile, single lumen support catheter, that consists of a reinforced polyimide shaft with a stainless steel tip, and PTFE polymer coated nitinol hypotube inside the shaft. The nitinol tube has a pre-shaped lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube can move at limited displacement inside the shaft, by moving a sliding knob in the catheter handle. The Upstream GoBack Crossing Catheter is intended for use with 0.014" and 0.018" non-coated quidewires and the effective length of the catheter is 120 cm with an outer diameter of 1.4 mm.
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