FDA 510(k) Application Details - K230594

Device Classification Name	More FDA Info for this Device
510(K) Number	K230594
Device Name	Tigereye ST CTO-Crossing Catheter
Applicant	Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Thomas Lawson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2023
Decision Date	04/25/2023
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