FDA 510(k) Application Details - K141054

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K141054
Device Name	Wire, Guide, Catheter
Applicant	DISTAL ACCESS, LLC 5010 HUEGA COURT PARK CITY, UT 84098 US Other 510(k) Applications for this Company
Contact	CAROL STAMP 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	04/18/2014
Decision Date	12/10/2014
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