FDA 510(k)

蜈蚣088通路針管

K 號：K231802 · 2023-09-19

決定日期2023-09-19

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Millipede 088 Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Perfuze, Ltd.. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K231802. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Millipede 088 Access Catheter?

Millipede 088 Access Catheter is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is Perfuze, Ltd.. The 510(k) number is K231802.

When did Millipede 088 Access Catheter receive FDA 510(k) clearance?

Millipede 088 Access Catheter received FDA 510(k) clearance on 2023-09-19, under 510(k) number K231802.

Who is the listed applicant for Millipede 088 Access Catheter?

FDA 510(k) 記錄將 Perfuze, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Millipede 088 Access Catheter?

The FDA product code for Millipede 088 Access Catheter is QJP.

其他以 Perfuze, Ltd. 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。

K262399蜈蚣系統 K253901蟻蟻88 接通導管 K253590蜈蚣系統 K252392Millipede70 吸引針管；Perfuze 吸引管路組 K250012蜈蚣070 吸引針管；Perfuze 吸引管路組 K240711Zipline 接觸導管

查看所有 11 項裝置 →

相關器械（代碼：QJP）

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。

K260220路92醫療全長046進入系統Route 92 Medical, Inc.K26227770 神經導引針管Piraeus Medical, Inc.K261176Zoom 4S 管針Imperative Care, Inc.K254071p17 XR 微导管Wallaby Medical K260199SLIM 微导管Balt USA, LLC K253901蟻蟻88 接通導管Perfuze, Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。