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510(k) K242503

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) by Eurosets Srl — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2025
Date Received
August 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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  • K141492 — ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) (February 6, 2015)
  • K102109 — ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOT (February 15, 2011)

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  • K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator V (September 12, 2024)
  • K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac (July 10, 2024)
  • K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity (June 12, 2024)
  • K231652 — D100 KIDS; D101 KIDS (November 16, 2023)
  • K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quant (November 8, 2023)
  • K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (November 1, 2023)
  • K230640 — Affinity Fusion™ Oxygenator System (April 6, 2023)
  • K223161 — OXY-1 System (February 23, 2023)