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FDA 510(k)

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

K-Number: K162803 · 2017-07-14

ApplicantVascutek, Ltd.
Decision Date2017-07-14
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is a medical device manufactured by Vascutek, Ltd.. It received FDA 510(k) clearance on 2017-07-14 under approval number K162803. 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 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Vascutek, Ltd.. The 510(k) number is K162803.

When was Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts approved by the FDA?

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts received FDA 510(k) clearance on 2017-07-14, under approval number K162803.

What company makes Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is manufactured by Vascutek, Ltd..

What is the FDA product code for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

The FDA product code for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is DSY.

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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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