Clearance Summary
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) received FDA 510(k) clearance under submission number K223879, sponsored by Quara S.R.L.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-04-13.
- Submission: K223879
- Applicant / Sponsor: Quara S.R.L.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4240
- Decision date: 2023-04-13
Classification & Regulation
This clearance is catalogued under FDA product code DTR and 21 CFR 870.4240, within the Cardiovascular review panel as a Class II device.