FDA 510(k) Application Details - K170406

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K170406
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 US Other 510(k) Applications for this Company
Contact	David Sabodski 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	02/10/2017
Decision Date	04/18/2017
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	Y
Expedited Review