Device type
Heat-Exchanger, Cardiopulmonary Bypass
Product code DTR · Class II · 21 CFR 870.4240 · Cardiovascular
Recent 510(k)s
No 510(k) clearances in the archive for DTR.
Recent recalls
Oct 7, 2026
Z-3327-2026
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Produ…
SPECTRUM MEDICAL SRL
- DTR
- Class II
- Ongoing
Oct 7, 2026
Z-3328-2026
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product…
SPECTRUM MEDICAL SRL
- DTR
- Class II
- Ongoing