FDA 510(k) Application Details - K240967

Device Classification Name	More FDA Info for this Device
510(K) Number	K240967
Device Name	ValvuloPro Valvuloplasty Balloon Catheter
Applicant	Dongguan TT Medical, Inc. Bld #1, Rm 501, 502,Taoyuan Rd Songshan Lake 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	04/09/2024
Decision Date	07/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review