K240193
- 510(k) number
- K240193
- Device name
- R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2024-02-22
- Date received
- 2024-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240193.pdf
Official FDA record: K240193
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.