K250937
- 510(k) number
- K250937
- Device name
- Venous Return Cannulae
- Applicant
- LivaNova USA, Inc. CO · US
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2026-03-11
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250937.pdf
Official FDA record: K250937
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.