FDA 510(k)

NeVa 靜脈血栓切除裝置

K 號：K253407 · 2025-11-24

決定日期2025-11-24

產品代碼QEX

諮詢委員會履歷

決定Unknown

器材摘要

NeVa PV Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio, Inc.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K253407. The device is classified under product code QEX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常見問題

What is the NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Vesalio, Inc.. The 510(k) number is K253407.

When did NeVa PV Thrombectomy Device receive FDA 510(k) clearance?

NeVa PV Thrombectomy Device received FDA 510(k) clearance on 2025-11-24, under 510(k) number K253407.

Who is the listed applicant for NeVa PV Thrombectomy Device?

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 NeVa PV Thrombectomy Device?

The FDA product code for NeVa PV Thrombectomy Device is QEX.

其他以 Vesalio, Inc. 為申請人之記錄

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相關器械（代碼：QEX）

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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