Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W— 510(k) K252541
Substantially EquivalentSpectrum Medical S.R.L.
FDA 510(k) clearance K252541 for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W, Substantially Equivalent on 2026-03-12. Applicant: Spectrum Medical S.R.L.. Device class: 2.
Clearance details
- Applicant
- Spectrum Medical S.R.L.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
Recent devices under product code DTR
view all- K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K250150 — VANGUARD Blood cardioplegia Systems (3 models)
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
- K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
More clearances from Spectrum Medical S.R.L.
view all- K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more
- 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 DTR
product code DTR- Other
- 1
- Total
- 1
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.