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FDA 510(k)

Bridge Plus Occlusion Balloon (590-002)

K-Number: K251358 · 2025-06-24

ApplicantPhilips Image Guided Therapy Devices
Decision Date2025-06-24
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bridge Plus Occlusion Balloon (590-002) is a medical device manufactured by Philips Image Guided Therapy Devices. It received FDA 510(k) clearance on 2025-06-24 under approval number K251358. 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 Bridge Plus Occlusion Balloon (590-002)?

Bridge Plus Occlusion Balloon (590-002) is a medical device that received FDA 510(k) clearance on 2025-06-24. It is manufactured by Philips Image Guided Therapy Devices. The 510(k) number is K251358.

When was Bridge Plus Occlusion Balloon (590-002) approved by the FDA?

Bridge Plus Occlusion Balloon (590-002) received FDA 510(k) clearance on 2025-06-24, under approval number K251358.

What company makes Bridge Plus Occlusion Balloon (590-002)?

Bridge Plus Occlusion Balloon (590-002) is manufactured by Philips Image Guided Therapy Devices.

What is the FDA product code for Bridge Plus Occlusion Balloon (590-002)?

The FDA product code for Bridge Plus Occlusion Balloon (590-002) is MJN.

Related Clinical Trials

NCT03791970 Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries RECRUITING NCT07434726 In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta RECRUITING NCT07548281 Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions NOT_YET_RECRUITING NCT06798753 Occlusion Balloon vs. 5FR Ureteral Catheter COMPLETED

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)

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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