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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, Cutting/Scoring
510(k) Number K261778
Device Name JADE SCORE PTA Scoring Balloon Dilatation Catheter
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
#1 Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Applicant Contact Dora Zhang
Correspondent
OrbusNeich Medical (Shenzhen) Co., Ltd.
#1 Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Correspondent Contact Dora Zhang
Regulation Number870.1250
Classification Product Code
PNO  
Date Received05/29/2026
Decision Date 09/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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