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FDA 510(k)

GORE EMBOLIC FILTER

K-Number: K103500 · 2011-05-23

ApplicantW. L. Gore & Associates, Inc.
Decision Date2011-05-23
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE EMBOLIC FILTER is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2011-05-23 under 510(k) number K103500. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE EMBOLIC FILTER?

GORE EMBOLIC FILTER is a medical device that received FDA 510(k) clearance on 2011-05-23. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K103500.

When did GORE EMBOLIC FILTER receive FDA 510(k) clearance?

GORE EMBOLIC FILTER received FDA 510(k) clearance on 2011-05-23, under 510(k) number K103500.

Who is the listed applicant for GORE EMBOLIC FILTER?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE EMBOLIC FILTER?

The FDA product code for GORE EMBOLIC FILTER is NTE.

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Other records listing W. L. Gore & Associates, Inc. as applicant

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.

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Related Devices (Code: NTE)

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.

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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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