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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon Aortic Valvuloplasty
510(k) Number K260437
Device Name Valvuloplasty Balloon Catheter (ValvuloPro)
Applicant
Dongguan TT Medical, Inc.
Bld #1, Rm.501, 502,Taoyuan Rd.
Songshan Lake, Dongguan, Guangdong
Dongguan,  CN 523808
Applicant Contact Bi Yuying
Correspondent
Dongguan TT Medical, Inc.
Bld #1, Rm.501, 502,Taoyuan Rd.
Songshan Lake, Dongguan, Guangdong
Dongguan,  CN 523808
Correspondent Contact Bi Yuying
Regulation Number870.1255
Classification Product Code
OZT  
Date Received02/11/2026
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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