510(k) K031037 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
| Applicant | Medtronic Perfusion Systems, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 13, 2003 |
| Received | Apr 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422 Open, Classified |
DWF | None listed |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522 Open, Classified |
DWF | None listed |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622 Open, Classified |
DWF | None listed |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722 Open, Classified |
DWF | None listed |
| Jan 17, 2025 | Medtronic Perfusion Systems EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Open, Classified |
DWF | None listed |
| Aug 19, 2015 | Medtronic Perfusion Systems Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.