The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto Xp And Qwikmap Ep Navigation System.
| Device ID | K020863 |
| 510k Number | K020863 |
| Device Name: | CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | William Welch |
| Correspondent | William Welch BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-18 |
| Decision Date | 2003-01-09 |
| Summary: | summary |