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510(k) K250821

Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) by Eurosets S.R.L — Product Code DTZ

K250821 is an FDA 510(k) premarket notification submitted by Eurosets S.R.L for the device "Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Eurosets S.R.L has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
March 18, 2025
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

Other clearances by Eurosets S.R.L

  • K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (November 24, 2025)
  • K202510 — AMG PMP Infant (December 10, 2021)
  • K202206 — AMG PMP Pediatric (April 1, 2021)
  • 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)

Other clearances for product code DTZ

  • K253838 — Lifemotion Disposable Membrane Oxygenator (March 16, 2026)
  • K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Bl (March 12, 2026)
  • K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (November 24, 2025)
  • 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)

FDA data resources