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FDA 510(k)

PRECLUDE PERICARDIAL MEMBRANE

K-Number: K012098 · 2001-09-20

ApplicantW. L. Gore & Associates, Inc.
Decision Date2001-09-20
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRECLUDE PERICARDIAL MEMBRANE 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 2001-09-20 under 510(k) number K012098. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECLUDE PERICARDIAL MEMBRANE?

PRECLUDE PERICARDIAL MEMBRANE is a medical device that received FDA 510(k) clearance on 2001-09-20. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K012098.

When did PRECLUDE PERICARDIAL MEMBRANE receive FDA 510(k) clearance?

PRECLUDE PERICARDIAL MEMBRANE received FDA 510(k) clearance on 2001-09-20, under 510(k) number K012098.

Who is the listed applicant for PRECLUDE PERICARDIAL MEMBRANE?

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 PERICARDIAL MEMBRANE?

The FDA product code for PRECLUDE PERICARDIAL MEMBRANE is DXZ.

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

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Related Devices (Code: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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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