Device Classification Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
More FDA Info for this Device |
510(K) Number |
K113667 |
Device Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Applicant |
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper, UT 84020 US
Other 510(k) Applications for this Company
|
Contact |
KAREN JONES
Other 510(k) Applications for this Contact |
Regulation Number |
870.4290
More FDA Info for this Regulation Number |
Classification Product Code |
DTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/13/2011 |
Decision Date |
01/12/2012 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|