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

FDA 510(k)

GORE® PROPATEN® Vascular Graft

K-Number: K232312 · 2024-01-09

ApplicantW. L. Gore & Associates, Inc.
Decision Date2024-01-09
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE® PROPATEN® Vascular Graft is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2024-01-09 under approval number K232312. 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® PROPATEN® Vascular Graft?

GORE® PROPATEN® Vascular Graft is a medical device that received FDA 510(k) clearance on 2024-01-09. It is manufactured by W. L. Gore & Associates, Inc.. The 510(k) number is K232312.

When was GORE® PROPATEN® Vascular Graft approved by the FDA?

GORE® PROPATEN® Vascular Graft received FDA 510(k) clearance on 2024-01-09, under approval number K232312.

What company makes GORE® PROPATEN® Vascular Graft?

GORE® PROPATEN® Vascular Graft is manufactured by W. L. Gore & Associates, Inc..

What is the FDA product code for GORE® PROPATEN® Vascular Graft?

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

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT01619917 The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars RECRUITING NCT07557862 Multi-Site STARgraft (10401) Trial NOT_YET_RECRUITING NCT07555717 STARgraft (10401) Pilot RECRUITING NCT05729620 Evaluation of STARgraft-3 for Hemodialysis ACTIVE_NOT_RECRUITING NCT07216885 Solv Multi-Pass Hemodialysis System In-Center Clinical Study RECRUITING

Other Devices by W. L. Gore & Associates, Inc.

K160254GORE DrySeal Flex Introducer Sheath K163576GORE SYNECOR Preperitoneal Biomaterial K170740GORE VIABIL Short Wire Biliary Endoprosthesis K163217GORE BIO-A Tissue Reinforcement K181940GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement K173333GORE ENFORM Biomaterial

View all 24 devices →

Related Devices (Code: DSY)

K153523FUSION Vascular GraftMaquet Cardiovascular, LLC K172637HeRO GraftMerit Medical Systems, Inc. K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd. K162794Gelweave Vascular GraftsVascutek, Ltd. K180957exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs K183613exGraft, exGraft CarbonPeca Labs

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.

↑