PZS — Dual Lumen Ecmo Cannula Class II
Classification Details
- Product Code
- PZS
- Device Class
- Class II
- Regulation Number
- 870.4100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232480 | cardiacassist | ProtekDuo Veno-Venous Cannula Sets | October 6, 2023 |
| K203409 | mc3 | MC3 Crescent Jugular Dual Lumen Catheter | May 3, 2021 |
| K180151 | mc3 incorporated | MC3 Jugular Dual Lumen Catheter | July 16, 2018 |
| K171610 | mc3 incorporated | MC3 QuickFlow Dual Lumen Catheter | November 16, 2017 |