K252541
- 510(k) number
- K252541
- Device name
- Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
- Applicant
- Spectrum Medical S.R.L. IT
- Product code
- DTR — Heat-Exchanger, Cardiopulmonary Bypass
- Decision date
- 2026-03-12
- Date received
- 2025-08-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252541.pdf
Official FDA record: K252541
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.