FDA 510(k) Application Details - K162875

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K162875
Device Name	Filter, Intravascular, Cardiovascular
Applicant	NOVATE MEDICAL LTD. BLOCK 11, GALWAY TECHNOLOGY PARK, PARKMORE GALWAY IE Other 510(k) Applications for this Company
Contact	GORDON CROWLEY 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	10/14/2016
Decision Date	02/17/2017
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