FDA 510(k) Application Details - K231044

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K231044
Device Name	Catheter, Percutaneous
Applicant	Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921 US Other 510(k) Applications for this Company
Contact	Sandeep Chiplonkar 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	04/12/2023
Decision Date	07/27/2023
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