FDA 510(k) Application Details - K132728

Device Classification Name	More FDA Info for this Device
510(K) Number	K132728
Device Name	V8 TRANSLUMINAL BAV CATHETER
Applicant	INTERVALVE, INC 84801 73RD AVENUE 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	More FDA Info for this Regulation Number
Classification Product Code	OZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2013
Decision Date	11/22/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review