FDA 510(k) Application Details - K232647

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K232647
Device Name	Catheter, Percutaneous
Applicant	Surmodics. Inc. 9924 West 74th Street Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Jodie Christe Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2023
Decision Date	09/29/2023
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