FDA 510(k) Application Details - K122301

Device Classification Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K122301
Device Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant	VASCULAR SOLUTIONS ZERUSA LTD. 6464 SYCAMORE COURT MINNEAPOLIS, MN 55369 US Other 510(k) Applications for this Company
Contact	JENNIFER RUETHER 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	08/01/2012
Decision Date	09/07/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review