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FDA 510(k)

EPTFE SLFTM SPIRAL VASCULAR GRAFT

K-Number: K083169 · 2009-03-30

ApplicantTayside Flow Technologies Limited
Decision Date2009-03-30
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPTFE SLFTM SPIRAL VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Tayside Flow Technologies Limited. It received FDA 510(k) clearance on 2009-03-30 under 510(k) number K083169. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPTFE SLFTM SPIRAL VASCULAR GRAFT?

EPTFE SLFTM SPIRAL VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2009-03-30. The listed applicant is Tayside Flow Technologies Limited. The 510(k) number is K083169.

When did EPTFE SLFTM SPIRAL VASCULAR GRAFT receive FDA 510(k) clearance?

EPTFE SLFTM SPIRAL VASCULAR GRAFT received FDA 510(k) clearance on 2009-03-30, under 510(k) number K083169.

Who is the listed applicant for EPTFE SLFTM SPIRAL VASCULAR GRAFT?

The FDA 510(k) record lists Tayside Flow Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPTFE SLFTM SPIRAL VASCULAR GRAFT?

The FDA product code for EPTFE SLFTM SPIRAL VASCULAR GRAFT is DSY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Tayside Flow Technologies Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K094044SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT

Related Devices (Code: DSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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