FDA 510(k) Application Details - K241478

Device Classification Name	More FDA Info for this Device
510(K) Number	K241478
Device Name	Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Applicant	BrosMed Medical Co., Ltd. 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan 523808 CN Other 510(k) Applications for this Company
Contact	Crystal Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2024
Decision Date	10/22/2024
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