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FDA 510(k)

Bio-Medicus Life Support Catheter and Introducer

K 號：K251831 · 2026-01-15

申請人Medtronic, Inc.
決定日期2026-01-15
產品代碼QHW
諮詢委員會CV
決定Substantially Equivalent

器材摘要

Bio-Medicus Life Support Catheter and Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K251831. The device is classified under product code QHW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bio-Medicus Life Support Catheter and Introducer?

Bio-Medicus Life Support Catheter and Introducer is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Medtronic, Inc.. The 510(k) number is K251831.

When did Bio-Medicus Life Support Catheter and Introducer receive FDA 510(k) clearance?

Bio-Medicus Life Support Catheter and Introducer received FDA 510(k) clearance on 2026-01-15, under 510(k) number K251831.

Who is the listed applicant for Bio-Medicus Life Support Catheter and Introducer?

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

What is the FDA product code for Bio-Medicus Life Support Catheter and Introducer?

The FDA product code for Bio-Medicus Life Support Catheter and Introducer is QHW.

相關臨床試驗

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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其他以 Medtronic, 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。

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相關器械（代碼：QHW）

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。

K240534Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.K201057Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.

官方來源

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