FDA 510(k) Application Details - K163699

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K163699
Device Name	Filter, Intravascular, Cardiovascular
Applicant	ALN Implants Chirurgicaux 589 Chemin du Niel Bormes les Mimosas 83230 FR Other 510(k) Applications for this Company
Contact	Alain Nigon 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	12/29/2016
Decision Date	09/08/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review