FDA 510(k)

普拉圖17微導管

K 號：K223560 · 2023-08-21

決定日期2023-08-21

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Plato 17 Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, Inc.. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K223560. 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 Plato 17 Microcatheter?

Plato 17 Microcatheter is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Scientia Vascular, Inc.. The 510(k) number is K223560.

When did Plato 17 Microcatheter receive FDA 510(k) clearance?

Plato 17 Microcatheter received FDA 510(k) clearance on 2023-08-21, under 510(k) number K223560.

Who is the listed applicant for Plato 17 Microcatheter?

FDA 510(k) 記錄將Scientia Vascular, 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 Plato 17 Microcatheter?

The FDA product code for Plato 17 Microcatheter is QJP.

其他以 Scientia Vascular, 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。

K260223亞里士多德迷你導絲 K260002索福克勒斯吸引系統（索福克勒斯70吸引針）K253579Aristotle 14 導絲；Aristotle 18 導絲；Aristotle 24 導絲；Zoom Wire 14 導絲 K243938Aristotle 14 導絲; Aristotle 18 導絲; Aristotle 24 導絲; Zoom Wire 14 導絲; Aristotle Colossus 導絲 K242301索福克勒斯38導管 K223913索福克勒斯吸引系統

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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。

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官方來源

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