FDA 510(k) Application Details - K233505

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K233505
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	Jerry Cheung 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	10/31/2023
Decision Date	08/15/2024
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