Home / 510(k) Clearances / K203424

510(k) K203424

Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 by Qura S.R.L — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2021
Date Received
November 20, 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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  • K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity (June 12, 2024)
  • K231652 — D100 KIDS; D101 KIDS (November 16, 2023)
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