Single Lumen Ecmo Cannula
FDA product code QHW · Class II (moderate risk) · 21 CFR 870.4100 · Cardiovascular
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251831 | Bio-Medicus Life Support Catheter and IntroducerQHW · Traditional | Medtronic, Inc. | 01/15/2026SE |
| K240534 | Bio-Medicus Life Support Catheter and IntroducerQHW · Traditional | Medtronic, Inc. | 04/19/2024SE |
| K201057 | Bio-Medicus Life Support Catheter and IntroducerQHW · Traditional | Medtronic, Inc. | 01/14/2022SE |