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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K231608
Device Name Teleport XT Microcatheter
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
#1 Jinkui Rd., Futian Free Trade Zone
Shenzhen,  CN 518038
Applicant Contact Jerry Cheung
Correspondent
OrbusNeich Medical (Shenzhen) Co., Ltd.
#1 Jinkui Rd., Futian Free Trade Zone
Shenzhen,  CN 518038
Correspondent Contact Jerry Cheung
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/02/2023
Decision Date 01/07/2024
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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