FDA 510(k)

NeVasc 吸引系統

K 號：K251006 · 2025-11-10

決定日期2025-11-10

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

NeVasc Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio, Inc.. It received FDA 510(k) clearance on 2025-11-10 under 510(k) number K251006. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeVasc Aspiration System?

NeVasc Aspiration System is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is Vesalio, Inc.. The 510(k) number is K251006.

When did NeVasc Aspiration System receive FDA 510(k) clearance?

NeVasc Aspiration System received FDA 510(k) clearance on 2025-11-10, under 510(k) number K251006.

Who is the listed applicant for NeVasc Aspiration System?

FDA 510(k) 記錄將 Vesalio, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for NeVasc Aspiration System?

The FDA product code for NeVasc Aspiration System is NRY.

其他以 Vesalio, Inc. 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。

K254211pVasc Net 體內機械血栓切除裝置 K251097V-DAC 穿刺針 K253407NeVa 靜脈血栓切除裝置 K251312維薩利周邊系統

相關器械（代碼：NRY）

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

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