FDA 510(k) Application Details - K181202

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K181202
Device Name	Filter, Intravascular, Cardiovascular
Applicant	Novate Medical Ltd. Block 11, Galway Technology Park, Parkmore Galway H91 VE0H 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	05/07/2018
Decision Date	06/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review