FDA 510(k) Application Details - K201720

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K201720
Device Name	Wire, Guide, Catheter
Applicant	Beijing Bywave Sensing Medical Technology Co., Ltd. Room 501, Buildinctg 22, No.12, Juyuan Middle Road, Mapo Town, Shunyi District Beijing 101399 CN Other 510(k) Applications for this Company
Contact	Lizhe Zhang Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2020
Decision Date	02/18/2021
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