FDA 510(k) Application Details - K083127

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K083127
Device Name	Catheter, Percutaneous
Applicant	ASAHI INTECC CO., LTD. 2500 RED HILL AVE, 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	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2008
Decision Date	02/03/2009
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