FDA 510(k)

科德曼Certas Plus電子工具套件

K 號：K181902 · 2018-10-25

決定日期2018-10-25

產品代碼JXG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Codman Certas Plus Electronic Tool Kit is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K181902. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Codman Certas Plus Electronic Tool Kit?

Codman Certas Plus Electronic Tool Kit is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K181902.

When did Codman Certas Plus Electronic Tool Kit receive FDA 510(k) clearance?

Codman Certas Plus Electronic Tool Kit received FDA 510(k) clearance on 2018-10-25, under 510(k) number K181902.

Who is the listed applicant for Codman Certas Plus Electronic Tool Kit?

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

What is the FDA product code for Codman Certas Plus Electronic Tool Kit?

The FDA product code for Codman Certas Plus Electronic Tool Kit is JXG.

其他以 Integra Lifesciences Corp. 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。

K183581科德曼一次性穿釘器 K183406CereLink ICP 監護器，CereLink ICP 延長線 K182265CodMan Certas Plus 可編程閥

相關器械（代碼：JXG）

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。

K261004Codman® 遠端腹膜針管，铍白開口型（82-1682）；Codman® HOLTER® 腹膜針管（SALMON設計）（82-1684）Integra Lifesciences Production Corporation K251598智滴Brainspace, Inc.K250636Sophy Mini 單壓力閥 (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531科德曼Libertís分流針管搭配Bactiseal及Endexo技術Integra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD 腔管，配備 Bactiseal® 及 Endexo® 技術，並具有 Luer 接頭（821761）；Codman Libertís™ 1.9 mm EVD 腔管，配備 Bactiseal® 及 Endexo® 技術，並具有 Luer 接頭（821762）Integra Lifesciences Production Corporation

官方來源

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