Santreva™-ATK內血管再血管化針筒
K 號：K252315 · 2025-09-22
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器材摘要
Santreva™-ATK Endovascular Revasculariztion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is AngioSafe, Inc.. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K252315. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Santreva™-ATK Endovascular Revasculariztion Catheter?
Santreva™-ATK Endovascular Revasculariztion Catheter is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is AngioSafe, Inc.. The 510(k) number is K252315.
When did Santreva™-ATK Endovascular Revasculariztion Catheter receive FDA 510(k) clearance?
Santreva™-ATK Endovascular Revasculariztion Catheter received FDA 510(k) clearance on 2025-09-22, under 510(k) number K252315.
Who is the listed applicant for Santreva™-ATK Endovascular Revasculariztion Catheter?
The FDA 510(k) record lists AngioSafe, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Santreva™-ATK Endovascular Revasculariztion Catheter?
The FDA product code for Santreva™-ATK Endovascular Revasculariztion Catheter is PDU.
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：PDU）
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。
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