FDA 510(k)

Shiley成人柔軟擴張氣管切開管，配TaperGuard袖口

K 號：K193077 · 2020-06-01

決定日期2020-06-01

產品代碼JOH

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Covidien 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。

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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。

K251313Shiley™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XLTCovidien, LLC 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 GmbH K193133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 Incorporated K182861西利兒新生兒/兒童氣管切開管Covidien K173912BLUperc 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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