FDA 510(k) Application Details - K152485

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K152485
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	OSTIAL CORPORATION 1221 INNSBRUCK DRIVE SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	JAKE WOLENBERG 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	08/31/2015
Decision Date	02/16/2016
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