FDA 510(k) Application Details - K181126

Device Classification Name	More FDA Info for this Device
510(K) Number	K181126
Device Name	Reprocessed Visions PV .035 Digital IVUS Catheter
Applicant	Innovative Health, LLC 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 US Other 510(k) Applications for this Company
Contact	Amanda Babcock Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2018
Decision Date	01/18/2019
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