FDA 510(k) Application Details - K193653

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K193653
Device Name	Wire, Guide, Catheter
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	Ling Li 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	12/30/2019
Decision Date	08/26/2020
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