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FDA 510(k)

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

K-Number: K200955 · 2020-07-08

ApplicantVascutek, Ltd.
Decision Date2020-07-08
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch is a medical device manufactured by Vascutek, Ltd.. It received FDA 510(k) clearance on 2020-07-08 under approval number K200955. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch?

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch is a medical device that received FDA 510(k) clearance on 2020-07-08. It is manufactured by Vascutek, Ltd.. The 510(k) number is K200955.

When was Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch approved by the FDA?

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch received FDA 510(k) clearance on 2020-07-08, under approval number K200955.

What company makes Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch?

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch is manufactured by Vascutek, Ltd..

What is the FDA product code for Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch?

The FDA product code for Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch is DXZ.

Other Devices by Vascutek, Ltd.

K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts K162794Gelweave Vascular Grafts K202703Vascutek Gelsoft Plus ERS Vascular Graft K241070Gelsoft™ Plus Vascular Prostheses K241550Gelweave™ Vascular Prostheses PMA P210006Hybrid stent graft, thoracic aortic lesion treatment

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Related Devices (Code: DXZ)

K162579VascuCelAdmedus Regen Pty, Ltd. K152127CorMatrix TykeCormatrix Cardiovascular, Inc. K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. K240775PeriBeam® Pericardial MembraneTamabio

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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