FDA 510(k)

Bactiseal EVD 腔道針組合；Bactiseal 清晰 EVD 腔道針組合

K 號：K233448 · 2023-12-19

申請人Integra Lifesciences Production Corporation

決定日期2023-12-19

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

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2023-12-19 under 510(k) number K233448. 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 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K233448.

When did Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set receive FDA 510(k) clearance?

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set received FDA 510(k) clearance on 2023-12-19, under 510(k) number K233448.

Who is the listed applicant for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

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

What is the FDA product code for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

The FDA product code for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is JXG.

其他以 Integra Lifesciences Production Corporation 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。

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）K243531科德曼Libertís分流針管搭配Bactiseal及Endexo技術 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）K232890CereLink ICP 監護器（826820），CereLink ICP 延長線（826845）K233445Bactiseal 管腔內視鏡導管；Bactiseal 銀條條紋導管；Bactiseal 結腦室導管 K223330Certas Plus 可編程閥門

查看所有 9 項裝置 →

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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