Auryon 開心術系統
K 號：K260244 · 2026-04-10
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器材摘要
Auryon Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Eximo Medical. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260244. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Auryon Atherectomy System?
Auryon Atherectomy System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Eximo Medical. The 510(k) number is K260244.
When did Auryon Atherectomy System receive FDA 510(k) clearance?
Auryon Atherectomy System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260244.
Who is the listed applicant for Auryon Atherectomy System?
The FDA 510(k) record lists Eximo Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Auryon Atherectomy System?
The FDA product code for Auryon Atherectomy System is MCW.
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。
相關器械（代碼：MCW）
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。
K250723FreedomFlow™ 軌道環形動脈內脫落術系統 (H6005/ 4Fr 3-球體配置)Cardio Flow Inc.,K250385超級精英雷射動脈內切除針SpectraneticsK242757Rotarex 銳術系統Bard Peripheral Vascular, Inc.K242947FreedomFlow™ 軌道環形動脈內切除系統Cardio Flow Inc.,K241553Auryon 腺切除导管 1.7mm; Auryon 腺切除导管 1.7mm, 水性塗層Eximo Medical, Ltd.K233483FreedomFlow 軌道環形動脈內切除系統（H6004/5Fr 3-球體配置）Cardio Flow Inc.,
官方來源
在 FDA 資料庫中查看 →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。
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