Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS

K-Number: K093817 · 2010-01-07

ApplicantVascutek, Ltd.
Decision Date2010-01-07
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2010-01-07 under 510(k) number K093817. 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 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS?

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS is a medical device that received FDA 510(k) clearance on 2010-01-07. The listed applicant is Vascutek, Ltd.. The 510(k) number is K093817.

When did GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS receive FDA 510(k) clearance?

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS received FDA 510(k) clearance on 2010-01-07, under 510(k) number K093817.

Who is the listed applicant for GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS?

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 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS?

The FDA product code for GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 26 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.

↑