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510(k) K242588

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) by OrbusNeich Medical (Shenzhen) Co., Ltd. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2025
Date Received
August 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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