Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K221112 |
Device Name |
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) |
Applicant |
Biosense Webster, Inc. |
31 Technology Drive, Suite 200 |
Irvine,
CA
92618
|
|
Applicant Contact |
Phuong Park |
Correspondent |
Biosense Webster, Inc. |
31 Technology Drive, Suite 200 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Phuong Park |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 04/15/2022 |
Decision Date | 08/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|