FDA.reportPublic FDA data

510(k) K240934

Device
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
Applicant
Spectrum Medical S.R.L.
510(k) number
K240934
Product code
DTZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-12
Date received
2024-04-05
Regulation
870.4350
Classification name
Oxygenator, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Raffaella Tommasini
Address
Via Di Mezzo, 23 Mirandola IT 41037 41037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.2026-03-16
K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.L2025-12-12
K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L2025-11-24
K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L2024-09-12
K240666Affinity 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)Medtronic Perfusion Systems2024-07-10
K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)Medtronic, Inc.2024-06-12
K231652D100 KIDS; D101 KIDSSorin Group Italia S.R.L.2023-11-16
K231773Quantum 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-C1UQura S.R.L2023-11-08
K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical , Ltd.2023-11-01
K230640Affinity Fusion™ Oxygenator SystemMedtronic, Inc.2023-04-06
K223161OXY-1 SystemAbiomed, Inc.2023-02-23
K222297CentriMag Pre-connected PackAbbott2022-12-01
K212341Quantum 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,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2UQura S.R.L2022-01-28
K203424Quantum 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-E2Qura S.R.L2021-12-17
K202510AMG PMP InfantEurosets S.R.L2021-12-10