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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 K240967
Device Name ValvuloPro Valvuloplasty Balloon Catheter
Applicant
Dongguan TT Medical, Inc.
Bld #1, Rm.501, 502,Taoyuan Rd.
Songshan Lake
Dongguan,  CN 523808
Applicant Contact Yuying Bi
Correspondent
Dongguan TT Medical, Inc.
Bld #1, Rm.501, 502,Taoyuan Rd.
Songshan Lake
Dongguan,  CN 523808
Correspondent Contact Yuying Bi
Regulation Number870.1255
Classification Product Code
OZT  
Date Received04/09/2024
Decision Date 07/31/2024
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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