QEX
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Coronary Mechanical Thrombectomy With Aspiration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Medical specialty
- Cardiovascular
- FDA definition
- To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
- Adverse events (MAUDE)
- 2020: 30 · 2021: 81 · 2022: 16 · 2023: 25 · 2024: 25 · 2025: 24
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 |
|---|---|---|
| NeVa PV Thrombectomy Device (K253407) | Vesalio, Inc. | 2025-11-24 |
| MegaVac Mechanical Thrombectomy System (K171493) | Capture Vascular, Inc. | 2017-08-10 |
| INDIGO Aspiration System (K163618) | Penumbra, Inc. | 2017-05-24 |
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