K260195
- 510(k) number
- K260195
- Device name
- Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2026-04-23
- Date received
- 2026-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260195.pdf
Official FDA record: K260195
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.