Hopkinton, NY, US · 3 510(k) clearances · 3 PMAs · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | Class II | Cardiovascular | 2 | 2022-01-12 |
| DXF | — | — | — | 1 | 2021-07-19 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-07-06 | P150028-S007 | CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42 | Normal 180 Day Track | PNF | Aortic Stent | Unknown |
| 2021-12-13 | P150028-S006 | G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent | Normal 180 Day Track | PNF | Aortic Stent | Unknown |
| 2021-07-28 | P150028-S005 | NuDEL Delivery System | Real-Time Process | PNF | Aortic Stent | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-04-21 | Class II | Terminated | Z-1754-2025 | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 | — | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflat… |