FDA 510(k) Application Details - K152150

Device Classification Name	More FDA Info for this Device
510(K) Number	K152150
Device Name	V8 Balloon Aortic Valvuloplasty Catheter
Applicant	InterValve, Inc. 2445 Xenium Lane Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Mark Ungs 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	08/03/2015
Decision Date	12/18/2015
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