FDA 510(k) Application Details - K103405

Device Classification Name	More FDA Info for this Device
510(K) Number	K103405
Device Name	PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH
Applicant	VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 US Other 510(k) Applications for this Company
Contact	MATT NIENSTEDT 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	11/19/2010
Decision Date	12/22/2010
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