FDA 510(k) Application Details - K223026

Device Classification Name	More FDA Info for this Device
510(K) Number	K223026
Device Name	NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Applicant	Northeast Scientific, Inc. 2142 Thomaston Ave. Waterbury, CT 06704 US Other 510(k) Applications for this Company
Contact	Matt Farley 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	09/29/2022
Decision Date	02/03/2023
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