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FDA 510(k)

MODIFICATION TO EPTFE GRAFT

K-Number: K041528 · 2004-09-14

ApplicantVascutek, Ltd.
Decision Date2004-09-14
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EPTFE GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2004-09-14 under 510(k) number K041528. 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 MODIFICATION TO EPTFE GRAFT?

MODIFICATION TO EPTFE GRAFT is a medical device that received FDA 510(k) clearance on 2004-09-14. The listed applicant is Vascutek, Ltd.. The 510(k) number is K041528.

When did MODIFICATION TO EPTFE GRAFT receive FDA 510(k) clearance?

MODIFICATION TO EPTFE GRAFT received FDA 510(k) clearance on 2004-09-14, under 510(k) number K041528.

Who is the listed applicant for MODIFICATION TO EPTFE GRAFT?

The FDA 510(k) record lists Vascutek, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO EPTFE GRAFT?

The FDA product code for MODIFICATION TO EPTFE GRAFT is DSY.

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Other records listing Vascutek, Ltd. as applicant

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Related Devices (Code: DSY)

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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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