FDA 510(k) Application Details - K070945

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K070945
Device Name	Wire, Guide, Catheter
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	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2007
Decision Date	01/09/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review