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FDA 510(k)

GORE PRECLUDE VESSEL GUARD

K-Number: K061727 · 2006-08-07

ApplicantW. L. Gore & Associates, Inc.
Decision Date2006-08-07
Product CodeMFX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE PRECLUDE VESSEL GUARD 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 2006-08-07 under 510(k) number K061727. The device is classified under product code MFX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE PRECLUDE VESSEL GUARD?

GORE PRECLUDE VESSEL GUARD is a medical device that received FDA 510(k) clearance on 2006-08-07. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K061727.

When did GORE PRECLUDE VESSEL GUARD receive FDA 510(k) clearance?

GORE PRECLUDE VESSEL GUARD received FDA 510(k) clearance on 2006-08-07, under 510(k) number K061727.

Who is the listed applicant for GORE PRECLUDE VESSEL GUARD?

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 PRECLUDE VESSEL GUARD?

The FDA product code for GORE PRECLUDE VESSEL GUARD is MFX.

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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: MFX)

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.

K960532PRECLUDE IMA SLEEVEW. L. Gore & Associates, Inc.

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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