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510(k) K230631

Kodiak™ Dual Port Coaxial Introducer Kit by Argon Medical Devices — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2023
Date Received
March 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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