FDA 510(k) Application Details - K203390

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K203390
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	BrosMed Medical Co., Ltd. 15th building, SMEs Venture Park, Songshan Lake Hi-Tech Development Zone Dongguan 523808 CN Other 510(k) Applications for this Company
Contact	Wade 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	11/18/2020
Decision Date	04/14/2021
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
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