FDA 510(k)

Esperance 3+ 吸引針系統

K 號：K240917 · 2024-10-01

決定日期2024-10-01

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Esperance 3+ Aspiration Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K240917. 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 Esperance 3+ Aspiration Catheter System?

Esperance 3+ Aspiration Catheter System is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Wallaby Medical. The 510(k) number is K240917.

When did Esperance 3+ Aspiration Catheter System receive FDA 510(k) clearance?

Esperance 3+ Aspiration Catheter System received FDA 510(k) clearance on 2024-10-01, under 510(k) number K240917.

Who is the listed applicant for Esperance 3+ Aspiration Catheter System?

FDA 510(k) 記錄將 Wallaby Medical 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Esperance 3+ Aspiration Catheter System?

The FDA product code for Esperance 3+ Aspiration Catheter System is NRY.

其他以 Wallaby Medical 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。

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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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