FDA 510(k)

快速DeltaFuse

K 號：K252526 · 2025-08-26

決定日期2025-08-26

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Rapid DeltaFuse is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K252526. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rapid DeltaFuse?

Rapid DeltaFuse is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Ischemaview, Inc.. The 510(k) number is K252526.

When did Rapid DeltaFuse receive FDA 510(k) clearance?

Rapid DeltaFuse received FDA 510(k) clearance on 2025-08-26, under 510(k) number K252526.

Who is the listed applicant for Rapid DeltaFuse?

FDA 510(k) 記錄將 Ischemaview, 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 Rapid DeltaFuse?

The FDA product code for Rapid DeltaFuse is LLZ.

其他以 Ischemaview, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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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