FDA 510(k)

啟動HCR及HCR DUAL心臟切開儲存器

K 號：K251783 · 2025-12-22

決定日期2025-12-22

產品代碼DTN

諮詢委員會履歷

決定相當於

器材摘要

Inspire HCR and HCR DUAL cardiotomy reservoirs is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) number K251783. 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 Inspire HCR and HCR DUAL cardiotomy reservoirs?

Inspire HCR and HCR DUAL cardiotomy reservoirs is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K251783.

When did Inspire HCR and HCR DUAL cardiotomy reservoirs receive FDA 510(k) clearance?

Inspire HCR and HCR DUAL cardiotomy reservoirs received FDA 510(k) clearance on 2025-12-22, under 510(k) number K251783.

Who is the listed applicant for Inspire HCR and HCR DUAL cardiotomy reservoirs?

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

What is the FDA product code for Inspire HCR and HCR DUAL cardiotomy reservoirs?

The FDA product code for Inspire HCR and HCR DUAL cardiotomy reservoirs is DTN.

其他以 Sorin Group Italia S.R.L. 為申請人之記錄

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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。

K241206量子灌流混合系統Spectrum Medical 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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