超級精英雷射動脈內切除針
K 號：K250385 · 2025-03-13
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器材摘要
Turbo-Elite Laser Atherectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K250385. 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 Turbo-Elite Laser Atherectomy Catheter?
Turbo-Elite Laser Atherectomy Catheter is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Spectranetics. The 510(k) number is K250385.
When did Turbo-Elite Laser Atherectomy Catheter receive FDA 510(k) clearance?
Turbo-Elite Laser Atherectomy Catheter received FDA 510(k) clearance on 2025-03-13, under 510(k) number K250385.
Who is the listed applicant for Turbo-Elite Laser Atherectomy Catheter?
The FDA 510(k) record lists Spectranetics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Turbo-Elite Laser Atherectomy Catheter?
The FDA product code for Turbo-Elite Laser Atherectomy Catheter 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。
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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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