FDA 510(k) Application Details - K160785

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K160785
Device Name	Wire, Guide, Catheter
Applicant	ARGON MEDICAL DEVICES, INC. 1445 FLAT CREEK ROAD ATHENS, TX 75751 US Other 510(k) Applications for this Company
Contact	SUZANNE CHEANG 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	03/22/2016
Decision Date	12/08/2016
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	N
Expedited Review