FDA 510(k) Application Details - K172258

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K172258
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Conavi Medical Inc. 293 Lesmill Road Toronto M3B2V1 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	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2017
Decision Date	04/27/2018
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