FDA 510(k) Application Details - K063371

Device Classification Name	More FDA Info for this Device
510(K) Number	K063371
Device Name	PRONTO V3 EXTRACTION CATHETER, MODEL 5003
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	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2006
Decision Date	12/14/2006
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