K240584
- 510(k) number
- K240584
- Device name
- XTRA Autotransfusion System (with XTRA Bowl sets)
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- CAC — Apparatus, Autotransfusion
- Decision date
- 2024-04-29
- Date received
- 2024-03-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240584.pdf
Official FDA record: K240584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.