Device Classification Name |
adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
|
510(k) Number |
K122301 |
Device Name |
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE |
Applicant |
VASCULAR SOLUTIONS ZERUSA LTD. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
JENNIFER RUETHER |
Correspondent |
VASCULAR SOLUTIONS ZERUSA LTD. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
JENNIFER RUETHER |
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 08/01/2012 |
Decision Date | 09/07/2012 |
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
|
|
|