FDA 510(k)

DuraSheath 引導鞘系統

K 號：K181463 · 2018-12-13

決定日期2018-12-13

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

DuraSheath Introducer Sheath System is the device name listed in this FDA 510(k) record. The listed applicant is Contract Medical International, GmbH. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K181463. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DuraSheath Introducer Sheath System?

DuraSheath Introducer Sheath System is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Contract Medical International, GmbH. The 510(k) number is K181463.

When did DuraSheath Introducer Sheath System receive FDA 510(k) clearance?

DuraSheath Introducer Sheath System received FDA 510(k) clearance on 2018-12-13, under 510(k) number K181463.

Who is the listed applicant for DuraSheath Introducer Sheath System?

The FDA 510(k) record lists Contract Medical International, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuraSheath Introducer Sheath System?

The FDA product code for DuraSheath Introducer Sheath System is DYB.

其他以 Contract Medical International, GmbH 為申請人之記錄

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相關器械（代碼：DYB）

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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官方來源

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