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FDA 510(k)

GORE® ACUSEAL Vascular Graft

K-Number: K231505 · 2023-06-23

ApplicantW. L. Gore & Associates, Inc.
Decision Date2023-06-23
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE® ACUSEAL Vascular Graft is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2023-06-23 under approval number K231505. 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 GORE® ACUSEAL Vascular Graft?

GORE® ACUSEAL Vascular Graft is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by W. L. Gore & Associates, Inc.. The 510(k) number is K231505.

When was GORE® ACUSEAL Vascular Graft approved by the FDA?

GORE® ACUSEAL Vascular Graft received FDA 510(k) clearance on 2023-06-23, under approval number K231505.

What company makes GORE® ACUSEAL Vascular Graft?

GORE® ACUSEAL Vascular Graft is manufactured by W. L. Gore & Associates, Inc..

What is the FDA product code for GORE® ACUSEAL Vascular Graft?

The FDA product code for GORE® ACUSEAL Vascular Graft is DSY.

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Related Devices (Code: DSY)

K153523FUSION Vascular GraftMaquet Cardiovascular, LLC K172637HeRO GraftMerit Medical Systems, Inc. K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd. K162794Gelweave Vascular GraftsVascutek, Ltd. K180957exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs K183613exGraft, exGraft CarbonPeca Labs

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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