Dual Lumen Ecmo Cannula
FDA product code PZS · Class II (moderate risk) · 21 CFR 870.4100 · Cardiovascular
Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232480 | ProtekDuo Veno-Venous Cannula SetsPZS · Traditional | Cardiacassist, Inc. | 10/06/2023SE |
| K203409 | MC3 Crescent Jugular Dual Lumen CatheterPZS · Traditional | Mc3, Inc. | 05/03/2021SE |
| K180151 | MC3 Jugular Dual Lumen CatheterPZS · Traditional | Mc3 Incorporated | 07/16/2018SE |
| K171610 | MC3 QuickFlow Dual Lumen CatheterPZS · Traditional | Mc3 Incorporated | 11/16/2017SE |