White Plains, NY, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class II | General Hospital | 2 | 2026-08-10 |
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | 2 | 2026-06-26 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class II | General Hospital | 1 | 2025-12-16 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General Hospital | 1 | 2025-07-30 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-10 | K260165 | Unimpregnated Central Venous Catheter | FOZ | Class II | General Hospital |
| 2026-06-26 | K261455 | Arterial Pressure Monitoring Set/Tray | DQO | Class II | Cardiovascular |
| 2026-03-25 | K254278 | Arterial Pressure Monitoring Set/Tray | DQO | Class II | Cardiovascular |
| 2025-12-16 | K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | LJS | Class II | General Hospital |
| 2025-07-30 | K250724 | Intraosseous Infusion Needles | FMI | Class II | General Hospital |
| 2024-11-27 | K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | FOZ | Class II | General Hospital |