The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Ep Navigation System, Version 4.2.
| Device ID | K133916 |
| 510k Number | K133916 |
| Device Name: | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD Diamond Bar, CA 91765 |
| Contact | Wayne R Hohman |
| Correspondent | Wayne R Hohman BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD Diamond Bar, CA 91765 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-07-01 |
| Summary: | summary |