FDA 510(k) Application Details - K232584

Device Classification Name	More FDA Info for this Device
510(K) Number	K232584
Device Name	Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
Applicant	Vein 360 LLC 4460 Lake Forest Dr Suite 230 Blue Ash, OH 45242-3741 US Other 510(k) Applications for this Company
Contact	Suzanne Meyer 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	08/25/2023
Decision Date	10/24/2023
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