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510(k) Data Aggregation
K Number
K211802Device Name
GoBack Crossing Catheter
Manufacturer
Date Cleared
2022-03-01
(264 days)
Product Code
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-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
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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K Number
K120964Device Name
UPSTREAM GR CATHETER
Manufacturer
Date Cleared
2012-05-25
(56 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
UPSTREAM PERIPHERAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Unstream GR Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Device Description
The Upstream GR Catheter is a sterile, single-use, dual-lumen catheter, having anchoring balloon and funnel at its distal tip, and Y-connector at its proximal end. The Upstream GR Catheter is intended for use with up to 0.035" guidewires. The Upstream GR Catheter is provided in 100 cm effective length and its shaft's outer diameter is 1.7mm (5F). A hub at the Y-connector center port, at the proximal end of the Upstream GR Catheter, allows guidewire access. The Y-connector side port is used for balloon inflation and deflation. The distal balloon is used for catheter anchoring and centering. The distal funnel is used as soft tip and soft stopper when an occlusion is reached.
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K Number
K112887Device Name
UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
Manufacturer
Date Cleared
2012-03-21
(173 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
UPSTREAM PERIPHERAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Upstream Needle Holder is intended to facilitate the placement of guidewires into the vascular system.
Device Description
The Upstream Needle Holder is a sterile, single lumen rigid polymer tube having male luer connector at the distal end to provide connection to standard needle, and female luer connectors at the proximal end for guidewire access. The Upstream Needle Holder with shut-off connector includes a standard shut-off connector. The shut-off connector includes a sliding element that opens and closes the connector lumen.
The Upstream Needle Holder is intended for use with guidewires of up to 0.0315" diameter. The Upstream Needle Holder is provided in a 23 cm length. The hub at distal end of the Upstream Needle Holder interfaces with a standard needle connection. The hub at the proximal end of the Upstream Needle Holder allows guidewire access, or connection of shut-off connector through which a guidewire is inserted and may be locked in position using the connector lock position.
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K Number
K112886Device Name
UPSTREAM SUPPORT CATHETER
Manufacturer
Date Cleared
2012-02-23
(146 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
UPSTREAM PERIPHERAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Upstream Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.
Device Description
The Upstream Support Catheter is a sterile, single lumen polymer coated stainless steel hypotube, with a tapered tip at the distal end and a proximal hub.
The Upstream Support Catheter is intended for use with 0.014" guidewires. The Upstream Support Catheter is provided in 95 cm length and its outer diameter is 0.8mm (0.0315"). A hub at the proximal end of the Upstream Support Catheter allows guidewire access.
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