FDA 510(k) Application Details - K230957

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K230957
Device Name	Catheter, Continuous Flush
Applicant	TriSalus Life Sciences 6272 W. 91st Avenue Westminster, CO 80031 US Other 510(k) Applications for this Company
Contact	Michael Aymami Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2023
Decision Date	05/02/2023
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	Y
Expedited Review