FDA 510(k) Application Details - K082385

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K082385
Device Name	Catheter, Percutaneous
Applicant	MICROVENTION, INC. 75 COLUMBIA ALISO VIEJO, CA 92656-1408 US Other 510(k) Applications for this Company
Contact	FLORIN TRUUVERT 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	08/19/2008
Decision Date	12/11/2008
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