FDA 510(k)

量子微心臟停跳輸送系統；量子微心臟停跳輸送模組（QMCDM）

K 號：K240908 · 2025-07-08

決定日期2025-07-08

產品代碼DTR

諮詢委員會履歷

決定相當於

器材摘要

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K240908. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K240908.

When did Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) receive FDA 510(k) clearance?

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) received FDA 510(k) clearance on 2025-07-08, under 510(k) number K240908.

Who is the listed applicant for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

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

What is the FDA product code for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

The FDA product code for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is DTR.

其他以 Spectrum Medical , Ltd. 為申請人之記錄

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相關器械（代碼：DTR）

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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