FDA 510(k) Application Details - K112674

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K112674
Device Name	Wire, Guide, Catheter
Applicant	NAVIS MEDICAL,INC 5705 WHISPERING TRL GALENA, OH 43021 US Other 510(k) Applications for this Company
Contact	MATTHEW J HUDDLESTON 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	09/14/2011
Decision Date	07/06/2012
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