Biotronick, Inc. · Class II · Cleared Oct 15, 2021
| K-number | K212593 |
| Device name | ViaCath, AcQRate Dx Steerable Catheter |
| Applicant | Biotronick, Inc. |
| Product code | DRF |
| Device class | Class II |
| Decision date | Oct 15, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 870.1220 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov