FDA 510(k)

OXY-1 系統

K 號：K223161 · 2023-02-23

決定日期2023-02-23

產品代碼DTZ

諮詢委員會履歷

決定相當於

器材摘要

OXY-1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K223161. 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 OXY-1 System?

OXY-1 System is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Abiomed, Inc.. The 510(k) number is K223161.

When did OXY-1 System receive FDA 510(k) clearance?

OXY-1 System received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223161.

Who is the listed applicant for OXY-1 System?

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

What is the FDA product code for OXY-1 System?

The FDA product code for OXY-1 System is DTZ.

其他以 Abiomed, Inc. 為申請人之記錄

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K25276614Fr 低輪廓引入器套件 K241708Abiomed 14Fr 低輪廓導管套件 K221294preCARDIA 閉塞系統 K222113Abiomed 14Fr 低輪廓導管組合 K202330Impella XR 套管組 K200109OXY-1 系統

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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.L K253838Lifemotion 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.L K242503Trilly兒童氧合器整合動脈過濾器（US5232）Eurosets S.R.L K231982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

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