FDA 510(k) Application Details - K230636

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K230636
Device Name	Catheter, Continuous Flush
Applicant	Merit Medical System, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Garry Courtney 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	03/07/2023
Decision Date	03/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review