Bedford, MA, US · 8 510(k) clearances · 7 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KRA | — | — | — | 3 | 2026-06-11 |
| FMF | — | — | — | 3 | 2025-12-22 |
| KRD | — | — | — | 2 | 2025-12-15 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-04-02 | P250003-S005 | Embrace Hydrogel Embolic System (HES) | Real-Time Process | QVG | — | — |
| 2026-04-01 | P250003-S006 | Embrace Hydrogel Embolic System (HES) | 30-Day Notice | QVG | — | — |
| 2026-02-12 | P250003-S004 | Embrace Hydrogel Embolic System (HES) | Special (Immediate Track) | QVG | — | — |
| 2026-02-04 | P250003-S003 | Embrace Hydrogel Embolic System | 30-Day Notice | QVG | — | — |
| 2025-12-17 | P250003-S002 | Embrace Hydrogel Embolic System (HES) | 30-Day Notice | QVG | — | — |
| 2025-11-25 | P250003-S001 | Embrace(TM) Hydrogel Embolic System | Real-Time Process | QVG | — | — |
| 2025-08-05 | P250003 | Embrace(TM) Hydrogel Embolic System | Original | QVG | — | — |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-11 | K261610 | Verge Microcatheter | KRA | — | — |
| 2025-12-22 | K253769 | Instylla Delivery Kit | FMF | — | — |
| 2025-12-15 | K253677 | Tembo Embolic System | KRD | — | — |
| 2024-12-16 | K240873 | TEMBO Embolic System | KRD | — | — |
| 2022-02-10 | K213632 | Instylla Delivery Kit | FMF | — | — |
| 2021-04-15 | K210808 | Instylla Microcatheter 1.2 | KRA | — | — |
| 2021-01-07 | K202544 | Instylla Delivery Kit | FMF | — | — |
| 2020-04-21 | K200744 | Instylla Microcatheter | KRA | — | — |