Carlsbad, CA, US · 5 510(k) clearances · 1 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | Class II | Gastroenterology, Urology | 2 | 2025-01-14 |
| FPA | Set, Administration, Intravascular | Class II | General Hospital | 1 | 2025-05-02 |
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | 1 | 2022-10-06 |
| FXX | Mask, Surgical | Class II | General, Plastic Surgery | 1 | 2020-08-19 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2024-10-17 | P120009-S004 | NIT-OCCLUD PDA | Normal 180 Day Track No User Fee | MAE | Occluder, Patent Ductus, Arteriosus | Unknown |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-05-02 | K242763 | JetCan® Pro Safety Huber Needle | FPA | Class II | General Hospital |
| 2025-01-14 | K241278 | ASEPT® Glide Peritoneal Drainage System | PNG | Class II | Gastroenterology, Urology |
| 2023-05-02 | K221779 | ASEPT Peritoneal Drainage System | PNG | Class II | Gastroenterology, Urology |
| 2022-10-06 | K213666 | NuCath Wedge Pressure Catheter | DQO | Class II | Cardiovascular |
| 2020-08-19 | K201137 | Asept Surgical Face Mask | FXX | Class II | General, Plastic Surgery |