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510(k) K213435

MAGIC Flow-Dependent Microcatheter by Balt USA, LLC — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2022
Date Received
October 22, 2021
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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  • K222679 — Vericor Support Catheter (November 7, 2022)