Cleared Traditional

SwiftNINJA Steerable Microcatheter

K211525 · Merit Medical Systems, Inc. · Cardiovascular
Jul 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K211525 is an FDA 510(k) clearance for the SwiftNINJA Steerable Microcatheter, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 16, 2021, 60 days after receiving the submission on May 17, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K211525 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2021
Decision Date July 16, 2021
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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