EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
FDA 510(k) clearance K031037 · decided 2003-05-13
Clearance details
- K-number
- K031037
- Device name
- EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
- Applicant
- Medtronic Perfusion Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-04-01
- Decision date
- 2003-05-13
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonar recall (Z-2806-2026) | Medtronic Perfusion Systems | 2026-07-27 |
| EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonar recall (Z-2807-2026) | Medtronic Perfusion Systems | 2026-07-27 |
| EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmon recall (Z-2808-2026) | Medtronic Perfusion Systems | 2026-07-27 |
| EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmon recall (Z-2809-2026) | Medtronic Perfusion Systems | 2026-07-27 |
| EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) recall (Z-0985-2025) | Medtronic Perfusion Systems | 2025-01-17 |
| Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygen recall (Z-2420-2015) | Medtronic Perfusion Systems | 2015-08-19 |