Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more— 510(k) K240934
Substantially EquivalentSpectrum Medical S.R.L.
FDA 510(k) clearance K240934 for Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more, Substantially Equivalent on 2026-03-12. Applicant: Spectrum Medical S.R.L.. Device class: 2.
Summary
Spectrum Medical's record lists three Quantum Perfusion Blood Oxygenators: ECC VT160-E3, ECC VT200-E3 and VT75- E3 (spaced that way in the record). They're filed under DTZ, cardiopulmonary bypass oxygenators.
Class II, 21 CFR 870.4350. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Spectrum Medical filed from Mirandola, Italy. The decision came 706 calendar days after receipt (April 5, 2024 to March 12, 2026).
Clearance details
- Device name as filed
- 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.
- Product code
- Product code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
Recent devices under product code DTZ
view all- K261438 — HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
- K253838 — Lifemotion Disposable Membrane Oxygenator
- K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more
- K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
- K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
More clearances from Spectrum Medical S.R.L.
view all- K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
- K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
- K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- K241206 — Quantum Perfusion Hybrid System
- K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.