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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 K231814
Device Name ValvuloPro Valvuloplasty Balloon Catheter
Applicant
Dongguan TT Medical, Inc.
Bld #1, Rm.501, 502, Taoyuan Rd.
Songshan Lake, Dongguan, Guangdong
Dongguan,  CN 523808
Applicant Contact Yuying Bi
Correspondent
Dongguan TT Medical, Inc.
Bld #1, Rm.501, 502, Taoyuan Rd.
Songshan Lake, Dongguan, Guangdong
Dongguan,  CN 523808
Correspondent Contact Yuying Bi
Regulation Number870.1255
Classification Product Code
OZT  
Date Received06/21/2023
Decision Date 10/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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