The following data is part of a premarket notification filed by Biotronick, Inc. with the FDA for Viacath, Acqrate Dx Steerable Catheter.
| Device ID | K212593 |
| 510k Number | K212593 |
| Device Name: | ViaCath, AcQRate Dx Steerable Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Biotronick, Inc. 6024 Jean Road Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh Biotronick, Inc. 6024 Jean Road Lake Oswego, OR 97035 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2021-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260090929018 | K212593 | 000 |
| 04260090929001 | K212593 | 000 |
| 04260090928998 | K212593 | 000 |
| 04260090928981 | K212593 | 000 |
| 04260090928974 | K212593 | 000 |
| 04260090926536 | K212593 | 000 |
| 04260090926529 | K212593 | 000 |