FDA 510(k) Application Details - K242893

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K242893
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Luma Vision Limited Block C, Parkview House-Beech Hill Office Campus Beech Hill Road Dublin D04 K5D0 IE Other 510(k) Applications for this Company
Contact	Marta Walker Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2024
Decision Date	03/24/2025
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