FDA 510(k)

微球體Embosphere

K 號：K250971 · 2025-05-16

決定日期2025-05-16

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

Embosphere Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, S.A.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K250971. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Embosphere Microspheres?

Embosphere Microspheres is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Biosphere Medical, S.A.. The 510(k) number is K250971.

When did Embosphere Microspheres receive FDA 510(k) clearance?

Embosphere Microspheres received FDA 510(k) clearance on 2025-05-16, under 510(k) number K250971.

Who is the listed applicant for Embosphere Microspheres?

The FDA 510(k) record lists Biosphere Medical, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Embosphere Microspheres?

The FDA product code for Embosphere Microspheres is KRD.

其他以 Biosphere Medical, S.A. 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。

K192480魚雷明膠泡沫 K183120EmboCube 間斷膠 K183578魚雷明膠泡沫 K181021EmboCube 間斷膠 K181300微球體Embosphere K172372四圓球微膠球

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相關器械（代碼：KRD）

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。

K252812UniPearls® 遮斷微膠球Suzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO 可調適性栓塊Boston Scientific Corporation K261866Concerto Versa™ 可拆式線圈Medtronic, Inc.K260635HARBOR 閉塞設備Nuvascular, Inc.K260508LOBO血管栓塞系統Okami Medical, Inc.K253511Concerto Versa™ 可拆式線圈Medtronic, Inc.

官方來源

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