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FDA 510(k)

VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH

K-Number: K963611 · 1996-11-21

ApplicantVascutek, Ltd.
Decision Date1996-11-21
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 1996-11-21 under 510(k) number K963611. 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 VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH?

VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH is a medical device that received FDA 510(k) clearance on 1996-11-21. The listed applicant is Vascutek, Ltd.. The 510(k) number is K963611.

When did VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH receive FDA 510(k) clearance?

VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH received FDA 510(k) clearance on 1996-11-21, under 510(k) number K963611.

Who is the listed applicant for VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH?

The FDA 510(k) record lists Vascutek, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH?

The FDA product code for VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH is DXZ.

Related Clinical Trials

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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Other records listing Vascutek, Ltd. 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.

K241550Gelweave™ Vascular ProsthesesK241070Gelsoft™ Plus Vascular ProsthesesK202703Vascutek Gelsoft Plus ERS Vascular GraftK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchK162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsK162794Gelweave Vascular Grafts

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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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