FDA 510(k) Application Details - K233637

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K233637
Device Name	Catheter, Percutaneous
Applicant	Cordis US Corp. 14201 NorthWest 60th Avenue Miami Lakes, FL 33014 US Other 510(k) Applications for this Company
Contact	Linda Ruedy 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	11/13/2023
Decision Date	06/28/2024
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