FDA 510(k) Application Details - K093993

Device Classification Name	Catheter, Intravascular, Plaque Morphology Evaluation   More FDA Info for this Device
510(K) Number	K093993
Device Name	Catheter, Intravascular, Plaque Morphology Evaluation
Applicant	Infraredx, Inc. 34 THIRD AVE BURLINGTON, MA 01803-4414 US Other 510(k) Applications for this Company
Contact	STEVEN J CHARTIER Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/2009
Decision Date	06/30/2010
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