FDA 510(k) Application Details - K163420

Device Classification Name	More FDA Info for this Device
510(K) Number	K163420
Device Name	UltraScore Focused Force PTA Balloon
Applicant	BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST TEMPE, AZ 85281 US Other 510(k) Applications for this Company
Contact	TIMOTHY WADE 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	12/06/2016
Decision Date	06/14/2017
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