K000190 is an FDA 510(k) clearance for the MODIFICATION TO CARTO EP NAVIGATION SYSTEM. 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 May 5, 2000, 113 days after receiving the submission on January 13, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K000190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2000 |
| Decision Date | May 05, 2000 |
| Days to Decision | 113 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 |