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FDA 510(k)

Bridge Occlusion Balloon

K-Number: K153530 · 2016-02-05

ApplicantSpectranetics, Inc.
Decision Date2016-02-05
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bridge Occlusion Balloon is a medical device manufactured by Spectranetics, Inc.. It received FDA 510(k) clearance on 2016-02-05 under approval number K153530. 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 Occlusion Balloon?

Bridge Occlusion Balloon is a medical device that received FDA 510(k) clearance on 2016-02-05. It is manufactured by Spectranetics, Inc.. The 510(k) number is K153530.

When was Bridge Occlusion Balloon approved by the FDA?

Bridge Occlusion Balloon received FDA 510(k) clearance on 2016-02-05, under approval number K153530.

What company makes Bridge Occlusion Balloon?

Bridge Occlusion Balloon is manufactured by Spectranetics, Inc..

What is the FDA product code for Bridge Occlusion Balloon?

The FDA product code for Bridge Occlusion Balloon 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)

Other Devices by Spectranetics, Inc.

K161333TightRail Sub-C Rotating Dilator Sheath K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K170059Spectranetics Turbo-Elite Laser Atherectomy Catheters K162561Turbo-Power (2.0mm) Laser Atherectomy Catheters K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K203540Bridge Occlusion Balloon

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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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