球節導向陣列（66295）
K 號：K250893 · 2025-09-04
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器材摘要
Ball Joint Guide Array (66295) 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 2025-09-04 under 510(k) number K250893. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ball Joint Guide Array (66295)?
Ball Joint Guide Array (66295) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K250893.
When did Ball Joint Guide Array (66295) receive FDA 510(k) clearance?
Ball Joint Guide Array (66295) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K250893.
Who is the listed applicant for Ball Joint Guide Array (66295)?
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 Ball Joint Guide Array (66295)?
The FDA product code for Ball Joint Guide Array (66295) is HAW.
相關臨床試驗
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其他以 Bayer Medical Care, Inc. 為申請人之記錄
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K253688MEDRAD® 影像大量包裝轉移針K252891MEDRAD MRXperion MR注射系統及MR注射系統針筒組；MEDRAD ISI2 模組（ISI2）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
相關器械（代碼：HAW）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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