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FDA 510(k)

PRECLUDE IMA SLEEVE

K-Number: K960532 · 1996-05-23

ApplicantW. L. Gore & Associates, Inc.
Decision Date1996-05-23
Product CodeMFX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRECLUDE IMA SLEEVE 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 1996-05-23 under 510(k) number K960532. 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 PRECLUDE IMA SLEEVE?

PRECLUDE IMA SLEEVE is a medical device that received FDA 510(k) clearance on 1996-05-23. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K960532.

When did PRECLUDE IMA SLEEVE receive FDA 510(k) clearance?

PRECLUDE IMA SLEEVE received FDA 510(k) clearance on 1996-05-23, under 510(k) number K960532.

Who is the listed applicant for PRECLUDE IMA SLEEVE?

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 IMA SLEEVE?

The FDA product code for PRECLUDE IMA SLEEVE 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.

K061727GORE PRECLUDE VESSEL GUARDW. 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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