FDA 510(k) Application Details - K113658

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K113658
Device Name	Device, Vascular, For Promoting Embolization
Applicant	AGA MEDICAL CORP. 5050 NATHAN LANE NORTH PLYMOUTH, MN 55442 US Other 510(k) Applications for this Company
Contact	SHERRY KOLLMANN 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	12/12/2011
Decision Date	06/12/2012
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