FDA 510(k)

Portex 藍線超幼兒氣管內管

K 號：K170720 · 2017-12-07

決定日期2017-12-07

產品代碼JOH

諮詢委員會AN

決定相當於

器材摘要

Portex Blue Line Ultra Paediatric Tracheosomy Tube is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K170720. 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 Portex Blue Line Ultra Paediatric Tracheosomy Tube?

Portex Blue Line Ultra Paediatric Tracheosomy Tube is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K170720.

When did Portex Blue Line Ultra Paediatric Tracheosomy Tube receive FDA 510(k) clearance?

Portex Blue Line Ultra Paediatric Tracheosomy Tube received FDA 510(k) clearance on 2017-12-07, under 510(k) number K170720.

Who is the listed applicant for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

The FDA product code for Portex Blue Line Ultra Paediatric Tracheosomy Tube is JOH.

其他以 Smiths Medical Asd, Inc. 為申請人之記錄

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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 K193077Shiley成人柔軟擴張氣管切開管，配TaperGuard袖口Covidien 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

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