FDA 510(k)

緊急經氣管氣道導管

K 號：K153761 · 2016-09-22

決定日期2016-09-22

產品代碼BWC

諮詢委員會AN

決定相當於

器材摘要

Emergency Transtracheal Airway Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K153761. The device is classified under product code BWC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Emergency Transtracheal Airway Catheter?

Emergency Transtracheal Airway Catheter is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Cook Incorporated. The 510(k) number is K153761.

When did Emergency Transtracheal Airway Catheter receive FDA 510(k) clearance?

Emergency Transtracheal Airway Catheter received FDA 510(k) clearance on 2016-09-22, under 510(k) number K153761.

Who is the listed applicant for Emergency Transtracheal Airway Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Emergency Transtracheal Airway Catheter?

The FDA product code for Emergency Transtracheal Airway Catheter is BWC.

其他以 Cook Incorporated 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：BWC）

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。

K200190刀片CricVBM Medizintechnik GmbH K160200梅克爾緊急氣管切开針套組，梅克爾通用氣管切开針套組Cook Incorporated

官方來源

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