FDA 510(k) Application Details - K053187

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K053187
Device Name	Wire, Guide, Catheter
Applicant	AGA MEDICAL CORP. 682 MENDELSSOHN AVE. GOLDEN VALLEY, MN 55427 US Other 510(k) Applications for this Company
Contact	PATRICIA A LAFORET 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	11/15/2005
Decision Date	04/27/2006
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