FX珊瑚40；FX珊瑚50
K 號：K253518 · 2025-12-18
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器材摘要
FX CorAL 40; FX CorAL 50 is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K253518. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FX CorAL 40; FX CorAL 50?
FX CorAL 40; FX CorAL 50 is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K253518.
When did FX CorAL 40; FX CorAL 50 receive FDA 510(k) clearance?
FX CorAL 40; FX CorAL 50 received FDA 510(k) clearance on 2025-12-18, under 510(k) number K253518.
Who is the listed applicant for FX CorAL 40; FX CorAL 50?
FDA 510(k) 記錄中將 Fresenius Medical Care Renal Therapies Group, LLC 列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for FX CorAL 40; FX CorAL 50?
The FDA product code for FX CorAL 40; FX CorAL 50 is KDI.
相關臨床試驗
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其他以 Fresenius Medical Care Renal Therapies Group, LLC 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：KDI）
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。
K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One 配 NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123)；multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo血液透析系統（PN-0008000，PN-0006000U）Outset Medical, Inc.K243920Purema H 血漿濃縮器 - 小兒用Medica USA, Inc.
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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