FDA 510(k) Application Details - K172584

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K172584
Device Name	Filter, Intravascular, Cardiovascular
Applicant	William Cook Europe ApS Sandet 6 Bjaeverskov 4632 DK Other 510(k) Applications for this Company
Contact	Henriette Stordal Christiansen 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	08/28/2017
Decision Date	11/20/2017
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