Medtronic, Inc. · Class II · Cleared Apr 23, 2026
| K-number | K260195 |
| Device name | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae |
| Applicant | Medtronic, Inc. |
| Product code | DWF |
| Device class | Class II |
| Decision date | Apr 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.4210 |
The EOPA 3D™ Arterial Cannulae are flexible, thin-walled cannulas designed to deliver blood to the ascending or descending aorta during cardiopulmonary bypass (CPB) procedures lasting up to 6 hours. The device features depth markings, an adjustable radiopaque suture ring, and is approximately 31.8 cm long with a tapered distal tip.
The device has identical operating principles, technological and engineering characteristics, design features, sterilization methods, shelf-life, materials of construction, and packaging to the predicate device. The only modifications are updated labeling to include descending aorta indications and minor labeling changes.
Not stated in this summary.
The EOPA 3D™ Arterial Cannulae are substantially equivalent to the predicate EOPA 3D Arterial Cannula (K150422) because they share the same design, operating principles, fundamental scientific technology, materials, sterilization requirements, and performance characteristics. The modifications are limited to labeling updates that do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov