FDA 510(k)

Shiley 成人可弯曲气管切开管带 TaperGuard Cuff

K号: K193077 · 2020-06-01

决定日期2020-06-01

产品代码JOH

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决定实质等同

器械摘要

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K193077. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff?

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Covidien. The 510(k) number is K193077.

When did Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff receive FDA 510(k) clearance?

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff received FDA 510(k) clearance on 2020-06-01, under 510(k) number K193077.

Who is the listed applicant for Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff?

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

What is the FDA product code for Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff?

The FDA product code for Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is JOH.

列明Covidien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。

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相关器械（代码：JOH）

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。

K251313Shiley™ 成人可弯曲气管切开管 XLT 带TaperGuard™ Cuff，远端带一次性内管；Shiley™ 成人可弯曲气管切开管 XLT 带TaperGuard™ Cuff，近端带一次性内管；Shiley™ 成人可弯曲气管切开管 XLT 无领，远端带一次性内管；Shiley™ 成人可弯曲气管切开管 XLT 无领，近端带一次性内管；Shiley™ 成人可弯曲一次性内管 XLTCovidien, LLC K210833Portex BLUxl 长型气管切开管，BLUxl 吸痰辅助长型气管切开管，BLUxl 长型气管切开管内芯Smiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbH K193133蓝色犀牛G1-多途径气管切开导引器套装，蓝色犀牛G1-多途径气管切开导引器托盘，蓝色犀牛G2-多途径气管切开导引器套装，蓝色犀牛G2-多途径气管切开导引器托盘，Weinmann-多途径气管切开交换套装Cook Incorporated K182861Shiley 新生儿/儿童气管切开管Covidien K173912BLUperc 经皮扩张气管造口套件，带 BLUselect 管道，BLUperc 经皮扩张气管造口套件，带 BLUselect 吸痰辅助管，BLUgriggs 经皮扩张气管造口套件，带 BLUselect 管道，BLUgriggs 经皮扩张气管造口套件，带 BLUselect 吸痰辅助管Smiths Medical Asd, Inc.

官方来源

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