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FDA 510(k)

GORE Molding and Occlusion Balloon Catheter

K-Number: K172567 · 2018-01-31

ApplicantW. L. Gore and Associates, Inc.
Decision Date2018-01-31
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE Molding and Occlusion Balloon Catheter is a medical device manufactured by W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2018-01-31 under approval number K172567. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE Molding and Occlusion Balloon Catheter?

GORE Molding and Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-01-31. It is manufactured by W. L. Gore and Associates, Inc.. The 510(k) number is K172567.

When was GORE Molding and Occlusion Balloon Catheter approved by the FDA?

GORE Molding and Occlusion Balloon Catheter received FDA 510(k) clearance on 2018-01-31, under approval number K172567.

What company makes GORE Molding and Occlusion Balloon Catheter?

GORE Molding and Occlusion Balloon Catheter is manufactured by W. L. Gore and Associates, Inc..

What is the FDA product code for GORE Molding and Occlusion Balloon Catheter?

The FDA product code for GORE Molding and Occlusion Balloon Catheter is MJN.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025)

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

K180919GORE Tri-Lumen Catheter K222919GORE® ENFORM Biomaterial PMA P200030SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Related Devices (Code: MJN)

K160598REBOA Balloon CatheterNuMED, Inc. K153530Bridge Occlusion BalloonSpectranetics, Inc. K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. K172790ER-REBOA CatheterPrytime Medical Devices, Inc. K170411ER-REBOA CatheterPrytime Medical Devices, Inc. K160067RenovoCathRenovorx, 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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