FDA 510(k) Application Details - K221411

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K221411
Device Name	Set, Administration, Intravascular
Applicant	Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Economic & Technological Development Zone Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Brian Byrd Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2022
Decision Date	06/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review