FDA 510(k) Application Details - K112103

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K112103
Device Name	Device, Vascular, For Promoting Embolization
Applicant	BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	HARLAN JONES 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	07/22/2011
Decision Date	08/12/2011
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