Total clearances
6
2022-11-28 → 2026-01-15
Name variants in FDA filings: Phenox Limited / Phenox, Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| POL |
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
Class II |
Neurology |
3 |
2025-02-28 |
| DQO |
Catheter, Intravascular, Diagnostic |
Class II |
Cardiovascular |
2 |
2024-11-12 |
| NRY |
Catheter, Thrombus Retriever |
Class II |
Cardiovascular |
1 |
2026-01-15 |
Filings
All 510(k) clearances (6)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-01-15 |
K251357 |
Esperance pHLO Aspiration System |
NRY |
Class II |
Cardiovascular |
| 2025-02-28 |
K242676 |
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device |
POL |
Class II |
Neurology |
| 2024-11-12 |
K242420 |
pNOVUS 21 Microcatheter |
DQO |
Class II |
Cardiovascular |
| 2023-10-21 |
K231539 |
pRESET LITE Thrombectomy Device |
POL |
Class II |
Neurology |
| 2023-01-20 |
K222848 |
pRESET Thrombectomy Device |
POL |
Class II |
Neurology |
| 2022-11-28 |
K221279 |
pNOVUS 21 Microcatheter |
DQO |
Class II |
Cardiovascular |