FDA 510(k)

Trilly兒童氧合器整合動脈過濾器（US5232）

K 號：K242503 · 2025-11-24

決定日期2025-11-24

產品代碼DTZ

諮詢委員會履歷

決定相當於

器材摘要

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is the device name listed in this FDA 510(k) record. The listed applicant is Eurosets S.R.L. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K242503. 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 Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Eurosets S.R.L. The 510(k) number is K242503.

When did Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) receive FDA 510(k) clearance?

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) received FDA 510(k) clearance on 2025-11-24, under 510(k) number K242503.

Who is the listed applicant for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?

FDA 510(k) 記錄將 Eurosets S.R.L 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?

The FDA product code for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is DTZ.

其他以 Eurosets S.R.L 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。

K261438HORIZON 8AF（整合OXY 模組 8AF 及 HORIZON CVR）（US5305）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）K202510AMG PMP 幼兒 K202206AMG PMP 小兒

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 K231982量子灌流血氧器 VT75-E1，量子灌流血氧器 VT75-E2Qura S.R.L K240666Affinity Fusion 氧合器配內置動脈濾器和平衡生物表面 (BB811)；Affinity Fusion 氧合器配內置動脈濾器和心臟切開/靜脈儲存器與平衡生物表面 (BB841)；Affinity Fusion 氧合器配內置動脈濾器和平衡生物表面非無菌型 (BB811-NS)Medtronic Perfusion Systems

官方來源

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