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FDA 510(k)

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

K-Number: K170622 · 2017-03-31

ApplicantCook Incorporated
Decision Date2017-03-31
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-03-31 under approval number K170622. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component?

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Cook Incorporated. The 510(k) number is K170622.

When was Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component approved by the FDA?

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component received FDA 510(k) clearance on 2017-03-31, under approval number K170622.

What company makes Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component?

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component is manufactured by Cook Incorporated.

What is the FDA product code for Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component?

The FDA product code for Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component is OQY.

Related Clinical Trials

NCT07471555 Vascular Access and Intraosseus ENROLLING_BY_INVITATION NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. RECRUITING

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Related Devices (Code: OQY)

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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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