CentriMag 預連接包
K 號：K222297 · 2022-12-01
廣告
器材摘要
CentriMag Pre-connected Pack is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K222297. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CentriMag Pre-connected Pack?
CentriMag Pre-connected Pack is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Abbott. The 510(k) number is K222297.
When did CentriMag Pre-connected Pack receive FDA 510(k) clearance?
CentriMag Pre-connected Pack received FDA 510(k) clearance on 2022-12-01, under 510(k) number K222297.
Who is the listed applicant for CentriMag Pre-connected Pack?
The FDA 510(k) record lists Abbott as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CentriMag Pre-connected Pack?
The FDA product code for CentriMag Pre-connected Pack is DTZ.
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。
其他以 Abbott 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。
相關器械（代碼：DTZ）
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。
K261438HORIZON 8AF（整合OXY 模組 8AF 及 HORIZON CVR）（US5305）Eurosets S.R.LK253838Lifemotion 一次性膠膜氧合器Lifemotion Medical Technology Co., Ltd.K240934量子灌流血氧器 ECC VT160-E3 (VT160-E3)；量子灌流血氧器 ECC VT200-E3 (VT200-E3)；量子灌流血氧器 VT75-E3 (VT75-E3)Spectrum Medical S.R.L.K250821Horizon AF Plus 系統（整合 A.L. One AF Plus 氧合器及 Horizon CVR）（US5300）；A.L. One AF Plus 氧合器（US5204）；Horizon CVR（US5073）Eurosets S.R.LK242503Trilly兒童氧合器整合動脈過濾器（US5232）Eurosets S.R.LK231982量子灌流血氧器 VT75-E1，量子灌流血氧器 VT75-E2Qura S.R.L
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。
廣告