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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
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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