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FDA 510(k)

GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE

K-Number: K914448 · 1991-11-05

ApplicantW. L. Gore & Associates, Inc.
Decision Date1991-11-05
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE 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 1991-11-05 under 510(k) number K914448. 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(R) CARDIOVASCULAR PATCH, PROCESS CHANGE?

GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K914448.

When did GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE receive FDA 510(k) clearance?

GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE received FDA 510(k) clearance on 1991-11-05, under 510(k) number K914448.

Who is the listed applicant for GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE?

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(R) CARDIOVASCULAR PATCH, PROCESS CHANGE?

The FDA product code for GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE 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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