K251783
- 510(k) number
- K251783
- Device name
- Inspire HCR and HCR DUAL cardiotomy reservoirs
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- DTN — Reservoir, Blood, Cardiopulmonary Bypass
- Decision date
- 2025-12-22
- Date received
- 2025-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251783.pdf
Official FDA record: K251783
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.