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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 the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics, Inc.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) 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. The listed applicant is Spectranetics, Inc.. The 510(k) number is K153530.

When did Bridge Occlusion Balloon receive FDA 510(k) clearance?

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

Who is the listed applicant for Bridge Occlusion Balloon?

The FDA 510(k) record lists Spectranetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bridge Occlusion Balloon?

The FDA product code for Bridge Occlusion Balloon is MJN.

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Related Devices (Code: MJN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, 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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