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510(k) Data Aggregation
K Number
K182937Device Name
Upstream GoBack Crossing Catheter
Manufacturer
Date Cleared
2019-05-23
(213 days)
Regulation Number
870.1250Why 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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