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FDA 510(k)

Aristotle 24 導絲, 200cm, 轟軟型; Aristotle 24 導絲, 200cm, 标準型; Aristotle 24 導絲, 200cm, 支援型

K 號：K192783 · 2019-10-30

申請人Scientia Vascular, LLC
決定日期2019-10-30
產品代碼DQX
諮詢委員會履歷
決定相當於

器材摘要

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile 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 2019-10-30 under 510(k) number K192783. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile?

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K192783.

When did Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile receive FDA 510(k) clearance?

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile received FDA 510(k) clearance on 2019-10-30, under 510(k) number K192783.

Who is the listed applicant for Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile?

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 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile?

The FDA product code for Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile is DQX.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K220398Aristotle 14 導絲；Aristotle 18 導絲；Aristotle 24 導絲；Volo 14 導絲；Zoom Wire 14 導絲K210601普拉圖17微導管K201760Zoom 14 導絲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：DQX）

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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