The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Ep Navigation System, Version 4.35 And Accessories With Coherent Map Module.
| Device ID | K173977 |
| 510k Number | K173977 |
| Device Name: | CARTO 3 EP Navigation System, Version 4.35 And Accessories With COHERENT MAP Module |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Biosense Webster, Inc. 33 Technology Drive Irvine, CA 92618 |
| Contact | Phuong Chau |
| Correspondent | Phuong Chau Biosense Webster, Inc. 33 Technology Drive Irvine, CA 92618 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-06-14 |
| Summary: | summary |