FDA 510(k) Application Details - K210313

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K210313
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	Shanghai MicroPort EP MedTech Co., Ltd. Building 23&28, Lane 588, Tianxiong Rd. Shanghai 201318 CN Other 510(k) Applications for this Company
Contact	Xia Tian Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2021
Decision Date	12/30/2022
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