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FDA 510(k)

Shiley™ 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 XLT

K号: K251313 · 2025-12-29

申请人Covidien, LLC
决定日期2025-12-29
产品代码JOH
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K251313. 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 Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT?

Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Covidien, LLC. The 510(k) number is K251313.

When did Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT receive FDA 510(k) clearance?

Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT received FDA 510(k) clearance on 2025-12-29, under 510(k) number K251313.

Who is the listed applicant for Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT?

FDA 510(k)记录中列出Covidien, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT?

The FDA product code for Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT is JOH.

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Covidien, LLC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。

K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层K253527Tri-Staple™ 2.0 黑色圆形加厚装填 21mm 超厚（SIGCIR21XT）；Tri-Staple™ 2.0 黑色圆形加厚装填 25mm 超厚（SIGCIR25XT）K253984Instrument Exit Point on Touch Surgery® AideK253030Capnostream™35 便携式呼吸监测仪 (PM35MN)K251025Mon-a-Therm®带温度传感器的食管听诊器400TM（90041, 90042, 90043, 90049）K250725Hugo® RAS 系统

查看所有 59 个设备 →

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。

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 GmbHK193077Shiley 成人可弯曲气管切开管带 TaperGuard CuffCovidienK193133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 IncorporatedK182861Shiley 新生儿/儿童气管切开管CovidienK173912BLUperc 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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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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