FDA 510(k) Application Details - K110584

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K110584
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	ASAHI INTECC CO., LTD. 2500 RED HILL SUITE 210 SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	YOSHI TERAI Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	MOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2011
Decision Date	08/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review