FDA 510(k) Application Details - K211807

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K211807
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	OrbusNeich Medical (Shenzhen) Co., Ltd. No.1 Jinkui Road, Futian Free Trade Zone Shenzhen 518038 CN Other 510(k) Applications for this Company
Contact	Daniel Zhang Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2021
Decision Date	10/14/2021
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