FDA 510(k) Application Details - K153125

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K153125
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Texas Medical Technologies, Inc. 9005 Montana Ave., Suite A El Paso, TX 79925 US Other 510(k) Applications for this Company
Contact	Aaron Chiu 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	10/29/2015
Decision Date	01/13/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review