FDA 510(k) Application Details - K212626

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K212626
Device Name	Introducer, Catheter
Applicant	Shanghai MicroPort EP MedTech Co., Ltd. Building 23&28, Lane 588, Tianxiong Rd. Shanghai CN Other 510(k) Applications for this Company
Contact	Tian Xia Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2021
Decision Date	03/23/2022
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