Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K173977 |
Device Name |
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module |
Applicant |
Biosense Webster, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Applicant Contact |
Phuong Chau |
Correspondent |
Biosense Webster, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Correspondent Contact |
Phuong Chau |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 12/29/2017 |
Decision Date | 06/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|