FDA 510(k) Application Details - K230418

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K230418
Device Name	Wire, Guide, Catheter
Applicant	Merit Medical Systems, Inc. 1600 Merit Pkwy Bldg 87 South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	James Kenny Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2023
Decision Date	10/28/2023
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