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 Tri-Lumen Catheter

K-Number: K180919 · 2018-10-05

ApplicantW. L. Gore and Associates, Inc.
Decision Date2018-10-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE Tri-Lumen Catheter is a medical device manufactured by W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2018-10-05 under approval number K180919. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE Tri-Lumen Catheter?

GORE Tri-Lumen Catheter is a medical device that received FDA 510(k) clearance on 2018-10-05. It is manufactured by W. L. Gore and Associates, Inc.. The 510(k) number is K180919.

When was GORE Tri-Lumen Catheter approved by the FDA?

GORE Tri-Lumen Catheter received FDA 510(k) clearance on 2018-10-05, under approval number K180919.

What company makes GORE Tri-Lumen Catheter?

GORE Tri-Lumen Catheter is manufactured by W. L. Gore and Associates, Inc..

What is the FDA product code for GORE Tri-Lumen Catheter?

The FDA product code for GORE Tri-Lumen Catheter is DQY.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED NCT07397390 an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions ENROLLING_BY_INVITATION

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

K172567GORE Molding and Occlusion Balloon Catheter K222919GORE® ENFORM Biomaterial PMA P200030SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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.

↑