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FDA 510(k)

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

K号: K170622 · 2017-03-31

申请人Cook Incorporated
决定日期2017-03-31
产品代码OQY
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Cook Incorporated. The 510(k) number is K170622.

When did Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component receive FDA 510(k) clearance?

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

Who is the listed applicant for Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component?

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

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Cook Incorporated为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233177Nest VT 液化设备K222254Gunther郁金香下腔静脉滤器回收套件K223098Bakri Essential Postpartum BalloonK210734血管内扩张器和套装K203670超大号Check-Flo导引器K191498Cook-Cope 环形肾造口套装，Ultrathane 肾造口套装带 Mac-Loc，Ultrathane 腹股沟套装带 Mac-Loc

查看所有 146 个设备 →

相关器械（代码：OQY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253642Jada 系统 (Jada-2002)Organon, LLCK230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.K223098Bakri Essential Postpartum BalloonCook IncorporatedK212757Jada 系统Alydia HealthK201199Jada 系统Alydia HealthK191264每秒都很重要-子宫球囊填塞（“ESM-UBT”）Ujenzi Charitable Trust

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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