The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Ep Navigation System With Advanced Focus Mapping (afm).
| Device ID | K221112 |
| 510k Number | K221112 |
| Device Name: | CARTO 3 EP Navigation System With Advanced Focus Mapping (AFM) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 |
| Contact | Phuong Park |
| Correspondent | Phuong Park Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-15 |
| Decision Date | 2022-08-17 |