FDA 510(k) Application Details - K231814

Device Classification Name	More FDA Info for this Device
510(K) Number	K231814
Device Name	ValvuloPro Valvuloplasty Balloon Catheter
Applicant	Dongguan TT Medical, Inc Bld #1, Rm 501, 502, Taoyuan Rd Songshan Lake, Dongguan, Guangdong Dongguan 523808 CN Other 510(k) Applications for this Company
Contact	Yuying Bi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2023
Decision Date	10/12/2023
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