FDA 510(k)

MEDRAD® 影像大量包裝轉移針

K 號：K253688 · 2026-06-12

決定日期2026-06-12

產品代碼PQH

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

MEDRAD® Imaging Bulk Package Transfer Spike is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253688. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MEDRAD® Imaging Bulk Package Transfer Spike?

MEDRAD® Imaging Bulk Package Transfer Spike is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K253688.

When did MEDRAD® Imaging Bulk Package Transfer Spike receive FDA 510(k) clearance?

MEDRAD® Imaging Bulk Package Transfer Spike received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253688.

Who is the listed applicant for MEDRAD® Imaging Bulk Package Transfer Spike?

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

What is the FDA product code for MEDRAD® Imaging Bulk Package Transfer Spike?

The FDA product code for MEDRAD® Imaging Bulk Package Transfer Spike is PQH.

其他以 Bayer Medical Care, 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。

K252891MEDRAD MRXperion MR注射系統及MR注射系統針筒組；MEDRAD ISI2 模組（ISI2）K250893球節導向陣列（66295）K200280醫療設備規範文本翻譯： MEDRAD影像大量包裝轉移針 K192370MEDRAD Stellant FLEX CT 注射系統搭配 Certegra 工作站 K193028MEDRAD 馬克7 頸動脈注射系統 K182273MEDRAD Stellant FLEX CT 注射系統搭配 Certegra 工作站，MEDRAD Stellant FLEX 静脈注射套件，MEDRAD Stellant CT 注射系統搭配 Certegra 工作站，MEDRAD Stellant 静脈注射套件，MEDRAD Stellant 接頭管路，P3T 心臟，P3T 肺動脈，P3T 腹部，ISI，Connect.CT

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相關器械（代碼：PQH）

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。

K193010萊貝-弗拉斯海姆 IBP 轉移組Liebel-Flarsheim Company, LLC K200280醫療設備規範文本翻譯： MEDRAD影像大量包裝轉移針Bayer Medical Care, Inc.K173913MEDRAD® 影像大量包裝轉移組Bayer U.S., LLC K161723烏爾里希傳輸設備Ulrich GmbH & Co. KG

官方來源

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