K250283
- 510(k) number
- K250283
- Device name
- RAP Femoral Venous Cannulae
- Applicant
- LivaNova USA, Inc. CO · US
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2025-07-10
- Date received
- 2025-01-31
- 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: K250283.pdf
Official FDA record: K250283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.