FDA 510(k) Application Details - K152765

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K152765
Device Name	Filter, Intravascular, Cardiovascular
Applicant	B.BRAUN INTERVENTIONAL SYSTEMS INC. 824 TWELFTH AVENUE BETHLEHEM, PA 18018 US Other 510(k) Applications for this Company
Contact	PETER FLOSDORF Other 510(k) Applications for this Contact
Regulation Number	870.3375   More FDA Info for this Regulation Number
Classification Product Code	DTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2015
Decision Date	02/26/2016
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