鳳凰鼻窦肌腱支架系統
K 號：K251382 · 2025-08-27
廣告
器材摘要
Phoenix Sinus Tarsi Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Astra Orthomed, Inc.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K251382. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Phoenix Sinus Tarsi Stent System?
Phoenix Sinus Tarsi Stent System is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Astra Orthomed, Inc.. The 510(k) number is K251382.
When did Phoenix Sinus Tarsi Stent System receive FDA 510(k) clearance?
Phoenix Sinus Tarsi Stent System received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251382.
Who is the listed applicant for Phoenix Sinus Tarsi Stent System?
The FDA 510(k) record lists Astra Orthomed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Phoenix Sinus Tarsi Stent System?
The FDA product code for Phoenix Sinus Tarsi Stent System is HWC. This falls under the Cardiovascular category.
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：HWC）
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。
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。
廣告