FDA 510(k) Application Details - K111338

Device Classification Name	More FDA Info for this Device
510(K) Number	K111338
Device Name	WILDCAT CATHETER
Applicant	AVINGER, INC. 755 MATHILDA AVENUE SUITE 100 SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	KIT CARIQUITAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2011
Decision Date	08/11/2011
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