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)

SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS

K-Number: K990503 · 1999-12-09

ApplicantSulzermedica
Decision Date1999-12-09
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Sulzermedica. It received FDA 510(k) clearance on 1999-12-09 under 510(k) number K990503. 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 SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS?

SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1999-12-09. The listed applicant is Sulzermedica. The 510(k) number is K990503.

When did SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS receive FDA 510(k) clearance?

SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS received FDA 510(k) clearance on 1999-12-09, under 510(k) number K990503.

Who is the listed applicant for SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS?

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

What is the FDA product code for SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS?

The FDA product code for SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS 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 Sulzermedica 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.

K002324MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMAK993667SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESISK993569APR METASUL ACETABULAR INSERTK992832SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS

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.

↑