FDA 510(k) Application Details - K110459

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K110459
Device Name	Catheter, Intravascular, Diagnostic
Applicant	SUREFIRE MEDICAL, INC 8601 TURNPIKE DR SUITE 206 WESTMINISTER, CO 80031 US Other 510(k) Applications for this Company
Contact	CHERYL HASTINGS 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	02/17/2011
Decision Date	06/24/2011
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