FDA 510(k) Application Details - K242126

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K242126
Device Name	Set, Administration, Intravascular
Applicant	BQ Plus medical Co.,Ltd. No. 18, Cheye Road, Chedun Town Shanghai 201611 CN Other 510(k) Applications for this Company
Contact	Jin Zhang 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	07/19/2024
Decision Date	08/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review