FDA 510(k) Application Details - K132990

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K132990
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 US Other 510(k) Applications for this Company
Contact	DIANE NELSON Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2013
Decision Date	10/22/2013
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