FDA 510(k)

索福克勒斯38導管

K 號：K242301 · 2024-12-04

決定日期2024-12-04

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Socrates 38 Catheter 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 2024-12-04 under 510(k) number K242301. 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 Socrates 38 Catheter?

Socrates 38 Catheter is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Scientia Vascular, Inc.. The 510(k) number is K242301.

When did Socrates 38 Catheter receive FDA 510(k) clearance?

Socrates 38 Catheter received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242301.

Who is the listed applicant for Socrates 38 Catheter?

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 Socrates 38 Catheter?

The FDA product code for Socrates 38 Catheter 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 K223913索福克勒斯吸引系統 K223560普拉圖17微導管

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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。

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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