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FDA 510(k)

Occlusion Balloon Catheter

K-Number: K183679 · 2019-04-24

ApplicantQxmedical, LLC
Decision Date2019-04-24
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Occlusion Balloon Catheter is a medical device manufactured by Qxmedical, LLC. It received FDA 510(k) clearance on 2019-04-24 under approval number K183679. 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 Occlusion Balloon Catheter?

Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-04-24. It is manufactured by Qxmedical, LLC. The 510(k) number is K183679.

When was Occlusion Balloon Catheter approved by the FDA?

Occlusion Balloon Catheter received FDA 510(k) clearance on 2019-04-24, under approval number K183679.

What company makes Occlusion Balloon Catheter?

Occlusion Balloon Catheter is manufactured by Qxmedical, LLC.

What is the FDA product code for Occlusion Balloon Catheter?

The FDA product code for 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 Qxmedical, LLC

K160561Boosting Catheter K200317Support Catheter

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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