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510(k) Data Aggregation
K Number
K094044Device Name
SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
Manufacturer
Date Cleared
2010-03-23
(82 days)
Product Code
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
TAYSIDE FLOW TECHNOLOGIES LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.
Device Description
The TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is to be used as an arteriovenous conduit for hemodialysis access. The graft has a specially designed section which is intended to induce spiral laminar flow. This section is designed to propagate spiral flow though the graft and into the distal circulation. TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft. The straight graft is combined with TFT's unique SLF™ external spiral flow inducer and inducer indicator, both made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane. The inducer indicator is a palpable ring over the proximal end of the spiral flow inducer. Its purpose is to indicate to the user where the spiral inducer segment begins since it is intended that cannulation in this segment should be avoided.
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K Number
K083169Device Name
EPTFE SLFTM SPIRAL VASCULAR GRAFT
Manufacturer
Date Cleared
2009-03-30
(154 days)
Product Code
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
TAYSIDE FLOW TECHNOLOGIES LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ePTFE SLF™ Spiral Vascular Grafts are indicated for use as vascular prostheses.
The device is intended for use in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.
Device Description
The device is a vascular graft which has a specially designed section intended to induce spiral laminar flow. The grafts are manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft, supplied by Vascutek Ltd.
The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading, injection moulded onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.
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