FDA 510(k)

迷你美德Flex泵

K 號：K253743 · 2026-03-12

決定日期2026-03-12

產品代碼QFG

諮詢委員會CH

決定相當於

器材摘要

MiniMed Flex pump is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed, Inc.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K253743. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MiniMed Flex pump?

MiniMed Flex pump is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Medtronic Minimed, Inc.. The 510(k) number is K253743.

When did MiniMed Flex pump receive FDA 510(k) clearance?

MiniMed Flex pump received FDA 510(k) clearance on 2026-03-12, under 510(k) number K253743.

Who is the listed applicant for MiniMed Flex pump?

The FDA 510(k) record lists Medtronic Minimed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniMed Flex pump?

The FDA product code for MiniMed Flex pump is QFG.

其他以 Medtronic Minimed, Inc. 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。

K253470MiniMed 780G 胰島素針筒 (MMT-1884)；MiniMed 780G 胰島素針筒組合包 (MMT-1894)K253585智慧守護技術；預測性低血糖技術 K251217智慧守護技術；預測性低血糖技術 K251032迷你美780G胰島素針筒 K210714延長式儲存器

相關器械（代碼：QFG）

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。

K260001薄荷ACE泵Beta Bionics, Inc.K261672twiist自動胰島素輸送（AID）系統Deka Research and Development K253976iLet ACE 泵Beta Bionics, Inc.K253470MiniMed 780G 胰島素針筒 (MMT-1884)；MiniMed 780G 胰島素針筒組合包 (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi 胰島素針筒配互操作性技術Tandem Diabetes Care, Inc.K252770iLet ACE 泵Beta Bionics, Inc.

官方來源

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