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Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U

FDA 510(k) clearance K231773 · decided 2023-11-08

Clearance details

K-number
K231773
Device name
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
Applicant
Qura S.R.L
Decision
Substantially Equivalent
Date received
2023-06-16
Decision date
2023-11-08
Days to decision
145 days
Clearance type
Traditional
Product code
DTZ
Device class
2
Regulation number
870.4350
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mirandola, IT
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Lifemotion Disposable Membrane Oxygenator (K253838)Lifemotion Medical Technology Co., Ltd.2026-03-16
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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) (K250821)Eurosets S.R.L2025-12-12
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (K242503)Eurosets S.R.L2025-11-24
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 (K231982)Qura S.R.L2024-09-12
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) (K240666)Medtronic Perfusion Systems2024-07-10
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) (K241352)Medtronic, Inc.2024-06-12
D100 KIDS; D101 KIDS (K231652)Sorin Group Italia S.R.L.2023-11-16
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (K231414)Chalice Medical , Ltd.2023-11-01
Affinity Fusion™ Oxygenator System (K230640)Medtronic, Inc.2023-04-06
OXY-1 System (K223161)Abiomed, Inc.2023-02-23
CentriMag Pre-connected Pack (K222297)Abbott2022-12-01

Recalls involving this device

No recalls on record reference this clearance.