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510(k) K243534

Micro Catheter by Suzhou Zenith Vascular SciTech Limited — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2025
Date Received
November 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

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