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.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- 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.