Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K132782 |
Device Name |
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 |
Applicant |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD |
DIAMOND BAR,
CA
91765
|
|
Applicant Contact |
WAYNE R HOHMAN |
Correspondent |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD |
DIAMOND BAR,
CA
91765
|
|
Correspondent Contact |
WAYNE R HOHMAN |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 09/06/2013 |
Decision Date | 01/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01385202
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|