Carlsbad, CA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Class II | Cardiovascular | 2 | 2024-09-06 |
| DRC | Trocar | Class II | Cardiovascular | 1 | 2024-07-26 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | 1 | 2024-02-16 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-09-06 | K233900 | Nordica PV Cryo Mapping Catheter | DRF | Class II | Cardiovascular |
| 2024-07-26 | K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | DRC | Class II | Cardiovascular |
| 2024-02-16 | K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | DYB | Class II | Cardiovascular |
| 2022-02-14 | K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | DRF | Class II | Cardiovascular |