FDA 510(k) Application Details - K173235

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K173235
Device Name	Wire, Guide, Catheter
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	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2017
Decision Date	01/22/2018
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	Y
Expedited Review