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FDA 510(k)

GELSOFT PLUS ERS

K-Number: K034010 · 2004-02-19

ApplicantVascutek, Ltd.
Decision Date2004-02-19
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GELSOFT PLUS ERS is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2004-02-19 under 510(k) number K034010. 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 GELSOFT PLUS ERS?

GELSOFT PLUS ERS is a medical device that received FDA 510(k) clearance on 2004-02-19. The listed applicant is Vascutek, Ltd.. The 510(k) number is K034010.

When did GELSOFT PLUS ERS receive FDA 510(k) clearance?

GELSOFT PLUS ERS received FDA 510(k) clearance on 2004-02-19, under 510(k) number K034010.

Who is the listed applicant for GELSOFT PLUS ERS?

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 GELSOFT PLUS ERS?

The FDA product code for GELSOFT PLUS ERS is DSY.

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Other records listing Vascutek, Ltd. as applicant

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K241550Gelweave™ Vascular ProsthesesK241070Gelsoft™ Plus Vascular ProsthesesK202703Vascutek Gelsoft Plus ERS Vascular GraftK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchK162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsK162794Gelweave Vascular Grafts

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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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