PZS
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dual Lumen Ecmo Cannula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Medical specialty
- Cardiovascular
- FDA 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.
- Adverse events (MAUDE)
- 2022: 28 · 2025: 35 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ProtekDuo Veno-Venous Cannula Sets (K232480) | Cardiacassist, Inc. | 2023-10-06 |
| MC3 Crescent Jugular Dual Lumen Catheter (K203409) | Mc3, Inc. | 2021-05-03 |
| MC3 Jugular Dual Lumen Catheter (K180151) | Mc3 Incorporated | 2018-07-16 |
| MC3 QuickFlow Dual Lumen Catheter (K171610) | Mc3 Incorporated | 2017-11-16 |
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Every clearance here is in the API, with alerts when new ones post.