K241236
- 510(k) number
- K241236
- Device name
- XTRA Collection sets; XTRA Sequestration set X
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- CAC — Apparatus, Autotransfusion
- Decision date
- 2024-08-16
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K241236.pdf
Official FDA record: K241236
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.