FDA 510(k) Application Details - K143405

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K143405
Device Name	Filter, Intravascular, Cardiovascular
Applicant	REX MEDICAL, LP 555 North Ln Suite 5035 Conshohocken, PA 19428 US Other 510(k) Applications for this Company
Contact	Erich Bressler 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	11/28/2014
Decision Date	04/16/2015
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