FDA 510(k) Application Details - K082746

Device Classification Name	System, Balloon, Intra-Aortic And Control   More FDA Info for this Device
510(K) Number	K082746
Device Name	System, Balloon, Intra-Aortic And Control
Applicant	INSIGHTRA MEDICAL, INC. 15560-C ROCKFIELD BLVD. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	TOM COLONNA Other 510(k) Applications for this Contact
Regulation Number	870.3535   More FDA Info for this Regulation Number
Classification Product Code	DSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2008
Decision Date	01/12/2009
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