FDA 510(k) Application Details - K202060

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K202060
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road Zibo 255086 CN Other 510(k) Applications for this Company
Contact	Liang Wanjie Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2020
Decision Date	07/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review