FDA 510(k)

Shiley 新生儿/儿童气管切开管

K号: K182861 · 2019-03-22

决定日期2019-03-22

产品代码JOH

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决定实质等同

器械摘要

Shiley Neonatal/Pediatric Tracheostomy Tube is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K182861. 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 Neonatal/Pediatric Tracheostomy Tube?

Shiley Neonatal/Pediatric Tracheostomy Tube is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Covidien. The 510(k) number is K182861.

When did Shiley Neonatal/Pediatric Tracheostomy Tube receive FDA 510(k) clearance?

Shiley Neonatal/Pediatric Tracheostomy Tube received FDA 510(k) clearance on 2019-03-22, under 510(k) number K182861.

Who is the listed applicant for Shiley Neonatal/Pediatric Tracheostomy Tube?

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 Neonatal/Pediatric Tracheostomy Tube?

The FDA product code for Shiley Neonatal/Pediatric Tracheostomy Tube 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 K193077Shiley 成人可弯曲气管切开管带 TaperGuard CuffCovidien 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 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.

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