FDA 510(k) Application Details - K241576

Device Classification Name	Catheter, Intravascular, Plaque Morphology Evaluation   More FDA Info for this Device
510(K) Number	K241576
Device Name	Catheter, Intravascular, Plaque Morphology Evaluation
Applicant	Infraredx, Inc. 28 Crosby Drive Suite 100 Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Stephen Sum Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2024
Decision Date	02/26/2025
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