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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K233505
Device Name Sapphire ULTRA Coronary Dilatation Catheter
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
No.1 Jinkui Road
Futian Free Trade Zone
Shenzhen,  CN 518038
Applicant Contact Jerry Cheung
Correspondent
OrbusNeich Medical (Shenzhen) Co., Ltd.
No.1 Jinkui Road
Futian Free Trade Zone
Shenzhen,  CN 518038
Correspondent Contact Jerry Cheung
Regulation Number870.5100
Classification Product Code
LOX  
Date Received10/31/2023
Decision Date 08/15/2024
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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