Device Classification Name |
dilator, vessel, surgical
|
510(k) Number |
K130896 |
Device Name |
VASCULAR PROBE, VASCULAR PROBE ES |
Applicant |
SYNOVIS LIFE TECHNOLOGIES, INC. |
2575 UNIVERSITY AVE. W. |
ST. PAUL,
MN
55114
|
|
Applicant Contact |
STEPHANI K AYALA |
Correspondent |
SYNOVIS LIFE TECHNOLOGIES, INC. |
2575 UNIVERSITY AVE. W. |
ST. PAUL,
MN
55114
|
|
Correspondent Contact |
STEPHANI K AYALA |
Regulation Number | 870.4475
|
Classification Product Code |
|
Date Received | 04/01/2013 |
Decision Date | 04/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|