FDA 510(k) Application Details - K221069

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K221069
Device Name	Set, Administration, Intravascular
Applicant	Sichuan Prius Biotechnology Co., Ltd. No.2 Prius Road, Luo Long Industrial Park Yibin 644104 CN Other 510(k) Applications for this Company
Contact	Yan Liu 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	04/12/2022
Decision Date	11/21/2022
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