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FDA 510(k)

GORE DrySeal Flex Introducer Sheath

K-Number: K160254 · 2016-05-12

ApplicantW. L. Gore & Associates, Inc.
Decision Date2016-05-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE DrySeal Flex Introducer Sheath is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2016-05-12 under approval number K160254. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE DrySeal Flex Introducer Sheath?

GORE DrySeal Flex Introducer Sheath is a medical device that received FDA 510(k) clearance on 2016-05-12. It is manufactured by W. L. Gore & Associates, Inc.. The 510(k) number is K160254.

When was GORE DrySeal Flex Introducer Sheath approved by the FDA?

GORE DrySeal Flex Introducer Sheath received FDA 510(k) clearance on 2016-05-12, under approval number K160254.

What company makes GORE DrySeal Flex Introducer Sheath?

GORE DrySeal Flex Introducer Sheath is manufactured by W. L. Gore & Associates, Inc..

What is the FDA product code for GORE DrySeal Flex Introducer Sheath?

The FDA product code for GORE DrySeal Flex Introducer Sheath is DYB.

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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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