FDA 510(k) Application Details - K171665

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K171665
Device Name	Catheter, Continuous Flush
Applicant	Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163 215163 CN Other 510(k) Applications for this Company
Contact	Jingwen Li Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2017
Decision Date	01/11/2018
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