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510(k) K211525

SwiftNINJA Steerable Microcatheter by Merit Medical Systems, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2021
Date Received
May 17, 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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  • K223139 — Wallaby 017 Micro Catheter (April 25, 2023)
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