FDA 510(k) Application Details - K193647

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K193647
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163 CN Other 510(k) Applications for this Company
Contact	Li Ling 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	12/30/2019
Decision Date	07/29/2020
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