FDA 510(k) Application Details - K250751

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K250751
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku Tokyo 151-0072 JP Other 510(k) Applications for this Company
Contact	Patrick McDonald Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2025
Decision Date	07/17/2025
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