FDA 510(k) Application Details - K083139

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K083139
Device Name	Catheter, Percutaneous
Applicant	CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	David Brooke Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2008
Decision Date	11/25/2008
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	Y
Expedited Review