FDA 510(k) Application Details - K031810

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K031810
Device Name	Device, Vascular, For Promoting Embolization
Applicant	AGA MEDICAL CORP. 682 MENDELSSOHN AVE. GOLDEN VALLEY, MN 55427 US Other 510(k) Applications for this Company
Contact	PATRICE M STROMBERG Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2003
Decision Date	09/09/2003
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