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FDA 510(k)

Aristotle 18 導絲, 200cm, 轟軟型; Aristotle 18 導絲, 200cm, 标準型; Aristotle 18 導絲, 200cm, 支援型

K 號：K183608 · 2019-03-22

申請人Scientia Vascular, LLC
決定日期2019-03-22
產品代碼MOF
諮詢委員會履歷
決定相當於

器材摘要

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 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 2019-03-22 under 510(k) number K183608. 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 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile?

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K183608.

When did Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile receive FDA 510(k) clearance?

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile received FDA 510(k) clearance on 2019-03-22, under 510(k) number K183608.

Who is the listed applicant for Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 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 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile?

The FDA product code for Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile is MOF.

相關臨床試驗

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。

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K192783Aristotle 24 導絲, 200cm, 轟軟型; Aristotle 24 導絲, 200cm, 标準型; Aristotle 24 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

查看所有 8 項裝置 →

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 VascularK26075135 鏈環導絲Piraeus Medical, Inc.K262424Willow 12 導絲Arbor Endovascular, LLCK260223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

在 FDA 資料庫中查看 →

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