K112007 is an FDA 510(k) clearance for the CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on October 5, 2011, 83 days after receiving the submission on July 14, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K112007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2011 |
| Decision Date | October 05, 2011 |
| Days to Decision | 83 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 |