FDA 510(k) Application Details - K151126

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K151126
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Colibri Technologies Inc. 293 Lesmill Road Toronto M3B 2V1 CA Other 510(k) Applications for this Company
Contact	SAM MOSTAFAVI Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2015
Decision Date	12/18/2015
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