FDA 510(k) Application Details - K111544

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K111544
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 PLEASANTON, CA 94566 US Other 510(k) Applications for this Company
Contact	SHIVA ARDAKANI Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2011
Decision Date	03/02/2012
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