FDA 510(k) Application Details - K111284

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K111284
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	OSTIAL CORPORATION 510 CLYDE AVENUE MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	Mark Smutka 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	05/06/2011
Decision Date	08/17/2011
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