FDA 510(k) Application Details - K162826

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K162826
Device Name	Set, Administration, Intravascular
Applicant	RyMed Technologies, LLC 6000 W. William Cannon Drive B300 Austin, TX 78749 US Other 510(k) Applications for this Company
Contact	Anna McCutchen Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2016
Decision Date	06/15/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review