Redmond, OR, US · 11 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | Class II | Cardiovascular | 6 | 2025-11-26 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Class II | Cardiovascular | 3 | 2025-06-05 |
| PNE | Reprocessed Catheter Introducer | Class II | Cardiovascular | 1 | 2025-12-19 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | Class II | General, Plastic Surgery | 1 | 2024-04-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-19 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | PNE | Class II | Cardiovascular |
| 2025-11-26 | K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | NLH | Class II | Cardiovascular |
| 2025-07-11 | K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | NLH | Class II | Cardiovascular |
| 2025-06-05 | K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | OWQ | Class II | Cardiovascular |
| 2025-03-10 | K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) | OWQ | Class II | Cardiovascular |
| 2024-11-29 | K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | NLH | Class II | Cardiovascular |
| 2024-09-14 | K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 | NLH | Class II | Cardiovascular |
| 2024-09-10 | K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) | OWQ | Class II | Cardiovascular |
| 2024-06-07 | K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | NLH | Class II | Cardiovascular |
| 2024-04-29 | K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | NUJ | Class II | General, Plastic Surgery |
| 2023-05-31 | K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | NLH | Class II | Cardiovascular |