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FDA 510(k)

GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM

K-Number: K912107 · 1991-10-11

ApplicantW. L. Gore & Associates, Inc.
Decision Date1991-10-11
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM 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 1991-10-11 under 510(k) number K912107. 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 GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM?

GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K912107.

When did GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM receive FDA 510(k) clearance?

GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM received FDA 510(k) clearance on 1991-10-11, under 510(k) number K912107.

Who is the listed applicant for GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM?

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-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM?

The FDA product code for GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM is DXZ.

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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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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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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