FDA 510(k)

量子灌流混合系統

K 號：K241206 · 2024-07-18

決定日期2024-07-18

產品代碼DTN

諮詢委員會履歷

決定相當於

器材摘要

Quantum Perfusion Hybrid System is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K241206. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Perfusion Hybrid System?

Quantum Perfusion Hybrid System is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K241206.

When did Quantum Perfusion Hybrid System receive FDA 510(k) clearance?

Quantum Perfusion Hybrid System received FDA 510(k) clearance on 2024-07-18, under 510(k) number K241206.

Who is the listed applicant for Quantum Perfusion Hybrid System?

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

What is the FDA product code for Quantum Perfusion Hybrid System?

The FDA product code for Quantum Perfusion Hybrid System is DTN.

其他以 Spectrum Medical S.R.L. 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：DTN）

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。

K251783啟動HCR及HCR DUAL心臟切開儲存器Sorin Group Italia S.R.L.K241053MVR™ 靜脈蓄血袋800毫升；MVR™ 静脈蓄血袋1600毫升；MVR™ 靜脈蓄血袋配Cortiva™ 生物活性表面800毫升；MVR™ 静脈蓄血袋配Cortiva™ 生物活性表面1600毫升Medtronic Cardiac Surgery K223361BMR 1900 體育器材規範文本Sorin Group Italia S.R.L.K170583Intersept過濾式心內切術容器，配Cortiva生物活性表面Medtronic, Inc.K161733INSPiRE SVR 1200, INSPiRE 6F C, INSPiRE 8F CSorin Group Italia S.R.L.

官方來源

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