Device Classification Name |
introducer, catheter
|
510(k) Number |
K231412 |
Device Name |
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) |
Applicant |
Biosense Webster, Inc. |
31 Technology Drive, Suite 200 |
Irvine,
CA
92618
|
|
Applicant Contact |
Caleb Lau |
Correspondent |
Biosense Webster, Inc. |
31 Technology Drive, Suite 200 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Caleb Lau |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/16/2023 |
Decision Date | 07/10/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|