K173977 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on June 14, 2018, 167 days after receiving the submission on December 29, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K173977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2017 |
| Decision Date | June 14, 2018 |
| Days to Decision | 167 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 |