FDA 510(k) Application Details - K113162

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K113162
Device Name	Wire, Guide, Catheter
Applicant	ACME-MONACO CORP. 75 WINCHELL DR. NEW BRITAIN, CT 06052 US Other 510(k) Applications for this Company
Contact	BENJAMIN SWEENEY 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	10/26/2011
Decision Date	07/20/2012
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