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FDA 510(k)

B7 2C Occlusion Balloon

K-Number: K171492 · 2017-11-20

ApplicantSpiration, Inc.
Decision Date2017-11-20
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

B7 2C Occlusion Balloon is a medical device manufactured by Spiration, Inc.. It received FDA 510(k) clearance on 2017-11-20 under approval number K171492. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B7 2C Occlusion Balloon?

B7 2C Occlusion Balloon is a medical device that received FDA 510(k) clearance on 2017-11-20. It is manufactured by Spiration, Inc.. The 510(k) number is K171492.

When was B7 2C Occlusion Balloon approved by the FDA?

B7 2C Occlusion Balloon received FDA 510(k) clearance on 2017-11-20, under approval number K171492.

What company makes B7 2C Occlusion Balloon?

B7 2C Occlusion Balloon is manufactured by Spiration, Inc..

What is the FDA product code for B7 2C Occlusion Balloon?

The FDA product code for B7 2C Occlusion Balloon is EOQ.

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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