FDA 510(k) Application Details - K093681

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K093681
Device Name	Wire, Guide, Catheter
Applicant	EV3 NEUROVASCULAR 9775 TOLEDO WAY IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	DEBORAH BAKER-JANIS Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2009
Decision Date	01/26/2010
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