Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae— 510(k) K260195
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K260195 for Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae, Substantially Equivalent on 2026-04-23. Applicant: Medtronic, Inc.. Device class: 2.
Summary
Medtronic's Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae are filed under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).
Class II, 21 CFR 870.4210. It came in as a Special 510(k), and Cardiovascular is both the classification panel and the review panel.
Medtronic filed from Mounds View, Minnesota. Review took 91 calendar days (January 22 to April 23, 2026).
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Product code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mounds View, MN, US
Recent devices under product code DWF
view allMore clearances from Medtronic, Inc.
view allAdverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K260195
K-number listed on FDA's recall record- Z-2810-2026 — EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
- Z-2811-2026 — EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K260195.
Data sourced from openFDA. This site is unofficial and independent of the FDA.