FDA 510(k)

解放者信標針固定式針筒

K 號：K170298 · 2017-10-18

決定日期2017-10-18

產品代碼DRB

諮詢委員會履歷

決定相當於

器材摘要

Liberator Beacon Tip Locking Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K170298. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Liberator Beacon Tip Locking Stylet?

Liberator Beacon Tip Locking Stylet is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Cook Incorporated. The 510(k) number is K170298.

When did Liberator Beacon Tip Locking Stylet receive FDA 510(k) clearance?

Liberator Beacon Tip Locking Stylet received FDA 510(k) clearance on 2017-10-18, under 510(k) number K170298.

Who is the listed applicant for Liberator Beacon Tip Locking Stylet?

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 Liberator Beacon Tip Locking Stylet?

The FDA product code for Liberator Beacon Tip Locking Stylet is DRB.

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：DRB）

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。

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469比奧特隆尼克針筒Biotronik, Inc.K182660GaltTWSGalt Medical Corp.

官方來源

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