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FDA 510(k)

GORE® ACUSEAL Vascular Graft

K-Number: K231505 · 2023-06-23

ApplicantW. L. Gore & Associates, Inc.
Decision Date2023-06-23
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE® ACUSEAL Vascular Graft 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 2023-06-23 under 510(k) number K231505. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE® ACUSEAL Vascular Graft?

GORE® ACUSEAL Vascular Graft is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K231505.

When did GORE® ACUSEAL Vascular Graft receive FDA 510(k) clearance?

GORE® ACUSEAL Vascular Graft received FDA 510(k) clearance on 2023-06-23, under 510(k) number K231505.

Who is the listed applicant for GORE® ACUSEAL Vascular Graft?

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® ACUSEAL Vascular Graft?

The FDA product code for GORE® ACUSEAL Vascular Graft is DSY.

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.

NCT05846581Registry of GORE® ACUSEAL Vascular Graft in Dialysis AccessRECRUITINGNCT02380716ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic DissectionCOMPLETEDNCT05409976The GORE® VIABAHN® FORTEGRA Venous Stent IVC StudyACTIVE_NOT_RECRUITINGNCT05489588The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral StudyACTIVE_NOT_RECRUITINGNCT05800743Evaluation of the GORE® Ascending Stent GraftENROLLING_BY_INVITATIONNCT06507865Post Market Registry for GORE® TAG® Thoracic Branch EndoprosthesisACTIVE_NOT_RECRUITING

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.

PMA P050006Transcatheter septal occluderPMA P210032SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTPMA P020004SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTPMA P230023Endovascular system for treatment of thoracoabdominal and pararenal aortic lesionsPMA P160021Iliac covered stent, arterialPMA P130006System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

View all 24 devices →

Related Devices (Code: DSY)

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.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. 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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