K221112 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM). This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on August 17, 2022, 124 days after receiving the submission on April 15, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K221112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2022 |
| Decision Date | August 17, 2022 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |