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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K212215
Device Name Tiche PTA Balloon Dilatation Catheter
Applicant
Brosmed Medical Co., Ltd.
2nd And 15th Bldg.S, Smes Venture Park,
Songshan Lake Hi-Tech Development Zone
Dongguan,  CN 523808
Applicant Contact Crystal Lee
Correspondent
Brosmed Medical Co., Ltd.
2nd And 15th Bldg.S, Smes Venture Park,
Songshan Lake Hi-Tech Development Zone
Dongguan,  CN 523808
Correspondent Contact Crystal Lee
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/15/2021
Decision Date 07/19/2022
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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