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510(k) K202510

AMG PMP Infant by Eurosets Srl — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2021
Date Received
August 31, 2020
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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  • 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

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  • 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)