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FDA 510(k)

Shiley™成人柔軟氣管切開管XLT搭配TaperGuard™袖口，遠端配用一次性內管；Shiley™成人柔軟氣管切開管XLT搭配TaperGuard™袖口，近端配用一次性內管；Shiley™成人柔軟氣管切開管XLT無袖口，遠端配用一次性內管；Shiley™成人柔軟氣管切開管XLT無袖口，近端配用一次性內管；Shiley™成人柔軟一次性內管XLT

K 號：K251313 · 2025-12-29

申請人Covidien, LLC
決定日期2025-12-29
產品代碼JOH
諮詢委員會AN
決定相當於

器材摘要

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.

常見問題

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) 記錄將 Covidien, LLC 列為申請人。這並不單獨確立設備製造商。

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Covidien, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261070LigaSure™ RAS 馬里蘭 頰部 血管 黏合器/分離器，納米塗層K253527Tri-Staple™ 2.0 黑色圓形重裝 21mm 過厚 (SIGCIR21XT)；Tri-Staple™ 2.0 黑色圓形重裝 25mm 過厚 (SIGCIR25XT)K253984觸術輔助™儀器之出氣點K253030Capnostream™35 輕便呼吸監測器 (PM35MN)K251025Mon-a-Therm™ 食管式聽診器配溫度感測器 400TM (90041, 90042, 90043, 90049)K250725Hugo™ RAS系統

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相關器械（代碼：JOH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K210833Portex BLUxl 長型氣管切開管，BLUxl 吸痰輔助長型氣管切開管，BLUxl 長型氣管切開管內管Smiths Medical Asd, Inc.K203362TRACOE 適用醫療設備規範文本Tracoe Medical GmbHK193077Shiley成人柔軟擴張氣管切開管，配TaperGuard袖口CovidienK193133藍犀牛G1-多孔經皮氣管造口導入組套，藍犀牛G1-多孔經皮氣管造口導入托盤，藍犀牛G2-多孔經皮氣管造口導入組套，藍犀牛G2-多孔經皮氣管造口導入托盤，威曼-多孔經皮氣管造口交換組套Cook IncorporatedK182861西利兒新生兒/兒童氣管切開管CovidienK173912BLUperc 皮穿刺擴張氣管造口套件搭配 BLUselect 管子，BLUperc 皮穿刺擴張氣管造口套件搭配 BLUselect 吸痰輔助管，BLUgriggs 皮穿刺擴張氣管造口套件搭配 BLUselect 管子，BLUgriggs 皮穿刺擴張氣管造口套件搭配 BLUselect 吸痰輔助管Smiths Medical Asd, Inc.

官方來源

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