FDA 510(k)

Aristotle 14 導絲；Aristotle 18 導絲；Aristotle 24 導絲；Volo 14 導絲；Zoom Wire 14 導絲

K 號：K220398 · 2023-03-10

決定日期2023-03-10

產品代碼MOF

諮詢委員會履歷

決定相當於

器材摘要

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, LLC. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K220398. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K220398.

When did Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire receive FDA 510(k) clearance?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire received FDA 510(k) clearance on 2023-03-10, under 510(k) number K220398.

Who is the listed applicant for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

The FDA 510(k) record lists Scientia Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

The FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is MOF.

其他以 Scientia Vascular, LLC 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。

K210601普拉圖17微導管 K201760Zoom 14 導絲 K192783Aristotle 24 導絲, 200cm, 轟軟型; Aristotle 24 導絲, 200cm, 标準型; Aristotle 24 導絲, 200cm, 支援型 K183608Aristotle 18 導絲, 200cm, 轟軟型; Aristotle 18 導絲, 200cm, 标準型; Aristotle 18 導絲, 200cm, 支援型 K181828Volo 14 導絲，200cm，柔軟型，Volo 14 導絲，200cm，標準型，Volo 14 導絲，300cm，柔軟型，Volo 14 導絲，300cm，標準型 K173235Aristotle 14 導絲，200cm，柔軟外觀，Aristotle 14 導絲，200cm，支持外觀，Aristotle 14 導絲，300cm，柔軟外觀，Aristotle 14 導絲，300cm，支持外觀

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相關器械（代碼：MOF）

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。

K254181亞里士多德65宏線Scientia Vascular K26075135 鏈環導絲Piraeus Medical, Inc.K262424Willow 12 導絲Arbor Endovascular, LLC K260223亞里士多德迷你導絲Scientia Vascular, Inc.K254006Drivewire 35 導絲Rapid Medical Ltd.K253579Aristotle 14 導絲；Aristotle 18 導絲；Aristotle 24 導絲；Zoom Wire 14 導絲Scientia Vascular, Inc.

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。