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510(k) K202366

MAGIC Infusion Catheter by Balt USA, LLC — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2021
Date Received
August 19, 2020
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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  • K230609 — NG Delivery Catheter (September 13, 2023)

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  • K223139 — Wallaby 017 Micro Catheter (April 25, 2023)
  • K223176 — Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Pl (April 10, 2023)
  • K230636 — Maestro Microcatheter (March 30, 2023)
  • K222679 — Vericor Support Catheter (November 7, 2022)