FDA 510(k) Application Details - K213004

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K213004
Device Name	Set, Administration, Intravascular
Applicant	Medcaptain Life Science Co., Ltd. 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	David Xia 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	09/20/2021
Decision Date	05/10/2022
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