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FDA 510(k)

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS

K-Number: K091778 · 2009-08-31

ApplicantVascutek, Ltd.
Decision Date2009-08-31
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2009-08-31 under 510(k) number K091778. 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 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS?

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS is a medical device that received FDA 510(k) clearance on 2009-08-31. The listed applicant is Vascutek, Ltd.. The 510(k) number is K091778.

When did VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS receive FDA 510(k) clearance?

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS received FDA 510(k) clearance on 2009-08-31, under 510(k) number K091778.

Who is the listed applicant for VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS?

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 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS?

The FDA product code for VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS 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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