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FDA 510(k)

Shiley™ 口腔/鼻腔 RAE 气管导管无领，Murphy 眼 (113-XX) Shiley™ 鼻腔 RAE 气管导管无领，Murphy 眼 (114-XX) Shiley™ 口腔 RAE 气管导管带领，Murphy 眼 (115-XX) Shiley™ 口腔 RAE 气管导管带 TaperGuard™ Cuff，Murphy 眼 (115-XXOR) Shiley™ 鼻腔 RAE 气管导管带 TaperGuard™ Cuff，Murphy 眼 (119-XXNR)

K号: K250173 · 2025-10-06

申请人Covidien, LLC
决定日期2025-10-06
产品代码BTR
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™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2025-10-06 under 510(k) number K250173. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)?

Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) is a medical device that received FDA 510(k) clearance on 2025-10-06. The listed applicant is Covidien, LLC. The 510(k) number is K250173.

When did Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) receive FDA 510(k) clearance?

Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) received FDA 510(k) clearance on 2025-10-06, under 510(k) number K250173.

Who is the listed applicant for Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)?

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™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)?

The FDA product code for Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) is BTR.

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）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 XLT

查看所有 59 个设备 →

相关器械（代码：BTR）

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。

K251794Tenax® 阻激光内窥镜气管导管Bryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK243785Shiley™ 口腔/鼻腔气管导管带 TaperGuard™ Cuff 加强型，Murphy 眼 Shiley™ 气管导管 TaperGuard™ Cuff 加强型带芯 Shiley™ 低轮廓口腔/鼻腔气管导管带领加强型 Shiley™ 低轮廓口腔/鼻腔气管导管带领加强型，Murphy 眼 Shiley™ 口腔/鼻腔气管导管无领加强型Covidien, LLCK243579AeroJet 通气导管Pipeline Medical Products, LLCK251499Frova插管引导器（C-CAE-14.0-70-FII）；Frova插管引导器（C-CAE-14.0-70-FI）；Frova插管引导器（C-CAE-14.0-70-FIC）；Frova插管引导器（C-CAE-14.0-70-FIC-SPOPS）William Cook Europe ApsK250243ProVu单次使用视频风格刀带增强ET管（尺寸6.5）（038-995-065U）；ProVu单次使用视频风格刀带带增强ET管（尺寸7.0）（038-995-070U）；ProVu单次使用视频风格刀带带增强ET管（尺寸7.5）（038-995-075U）；ProVu单次使用视频风格刀带带增强ET管（尺寸8.0）（038-995-080U）Flexicare Medical Limited.

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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