FDA 510(k) Application Details - K091703

Device Classification Name	More FDA Info for this Device
510(K) Number	K091703
Device Name	HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
Applicant	CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. MOUNTAIN VIEW, CA 94041 US Other 510(k) Applications for this Company
Contact	KIRSTEN VALLEY 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	06/10/2009
Decision Date	10/14/2009
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