FDA 510(k) Application Details - K152789

Device Classification Name	More FDA Info for this Device
510(K) Number	K152789
Device Name	FLEX SCORING CATHETER
Applicant	VENTUREMED GROUP 5855 MONROE ST SUITE 220 A SYLVANIA, OH 43560 US Other 510(k) Applications for this Company
Contact	TIFFINI DIAGE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2015
Decision Date	05/25/2016
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