FDA 510(k) Application Details - K083784

Device Classification Name	More FDA Info for this Device
510(K) Number	K083784
Device Name	PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
Applicant	VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT MINNEAPOLIS, MN 55369 US Other 510(k) Applications for this Company
Contact	CHARMAINE SUTTON 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	12/19/2008
Decision Date	03/30/2009
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