FDA 510(k)

Pathfinder® CR 系統

K 號：K240853 · 2024-06-27

決定日期2024-06-27

產品代碼FED

諮詢委員會GU

決定Unknown

器材摘要

Pathfinder® CR System is the device name listed in this FDA 510(k) record. The listed applicant is Neptune Medical, Inc.. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K240853. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Pathfinder® CR System?

Pathfinder® CR System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K240853.

When did Pathfinder® CR System receive FDA 510(k) clearance?

Pathfinder® CR System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K240853.

Who is the listed applicant for Pathfinder® CR System?

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

What is the FDA product code for Pathfinder® CR System?

The FDA product code for Pathfinder® CR System is FED.

其他以 Neptune Medical, Inc. 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。

K262262Pathfinder內視鏡外管 K260503翠龍1系統 K230801Pathfinder內視鏡外管充氣設備 K211301Pathfinder內視鏡外管 K210915Pathfinder內視鏡帽 K191415Pathfinder內視鏡外管

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相關器械（代碼：FED）

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。

K260512一次性輸尿管進入鞘Yangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder內視鏡外管Neptune Medical, Inc.K260410單次使用輸尿管進入鞘Zhejiang Chuangxiang Medical Technology Co., Ltd.K261915導航™ Flex 腎管進入鞘組合Boston Scientific Corporation K260965CVAC 吸引系統Calyxo, Inc.K260521ClearEVAC 腎管吸引進入鞘 (PUS-100-1040, PUS-100-1050, PUS-100-1240, PUS-100-1250)Zhuhai Pusen Medical Technology Co., 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。