510(k) K260195 · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Apr 23, 2026 |
| Received | Jan 22, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222 Open, Classified |
DWF | None listed |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322 Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.