K231207 is an FDA 510(k) clearance for the CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U). 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 September 7, 2023, 133 days after receiving the submission on April 27, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K231207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2023 |
| Decision Date | September 07, 2023 |
| Days to Decision | 133 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 |