FDA 510(k) Application Details - K212719

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K212719
Device Name	Catheter, Continuous Flush
Applicant	Suzhou Hengrui Hongyuan Medical Co., Ltd Building B9 Unit 201, No. 218 Xinghu Road, SIP Suzhou 215126 CN Other 510(k) Applications for this Company
Contact	Wang Peipei 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	08/27/2021
Decision Date	04/11/2022
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