FDA 510(k) Application Details - K250592

Device Classification Name	More FDA Info for this Device
510(K) Number	K250592
Device Name	NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
Applicant	Northeast Scientific, Inc. 2142 Thomaston Ave Waterbury, CT 06704 US Other 510(k) Applications for this Company
Contact	Matthew 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	02/27/2025
Decision Date	05/12/2025
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