FDA 510(k) Application Details - K161659

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K161659
Device Name	Introducer, Catheter
Applicant	LIBRA MEDICAL INC. 8401 73RD AVE NORTH SUITE 63 MINNEAPOLIS, MN 55428 US Other 510(k) Applications for this Company
Contact	SEW-WAH TAY Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2016
Decision Date	07/15/2016
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	Y
Expedited Review