K254085 is an FDA 510(k) clearance for the CARTO™ 3 EP Navigation System V9.0 with PIU Plus. 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 January 18, 2026, 31 days after receiving the submission on December 18, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K254085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2025 |
| Decision Date | January 18, 2026 |
| Days to Decision | 31 days |
| Submission Type | Special |
| 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 |