FDA 510(k) Application Details - K062877

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K062877
Device Name	Catheter, Intravascular, Diagnostic
Applicant	VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT MINNEAPOLIS, MN 55369 US Other 510(k) Applications for this Company
Contact	JULIE TAPPER Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2006
Decision Date	01/18/2007
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