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FDA 510(k)

PRECLUDE MVP DURA SUBSTITUTE

K-Number: K021477 · 2002-11-08

ApplicantW. L. Gore & Associates, Inc.
Decision Date2002-11-08
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRECLUDE MVP DURA SUBSTITUTE 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 2002-11-08 under 510(k) number K021477. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECLUDE MVP DURA SUBSTITUTE?

PRECLUDE MVP DURA SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K021477.

When did PRECLUDE MVP DURA SUBSTITUTE receive FDA 510(k) clearance?

PRECLUDE MVP DURA SUBSTITUTE received FDA 510(k) clearance on 2002-11-08, under 510(k) number K021477.

Who is the listed applicant for PRECLUDE MVP DURA SUBSTITUTE?

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 PRECLUDE MVP DURA SUBSTITUTE?

The FDA product code for PRECLUDE MVP DURA SUBSTITUTE is GXQ.

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

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Related Devices (Code: GXQ)

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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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