FDA 510(k) Application Details - K201929

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K201929
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Shanghai Kindly Medical Instruments Co., Ltd. No. 925 Jinyuan yi Road Shanghai 201803 CN Other 510(k) Applications for this Company
Contact	Xu Jianhai Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2020
Decision Date	05/14/2021
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