Cleared Traditional

Mighty Wire Guide Wire

K230418 · Merit Medical Systems, Inc. · Cardiovascular
Oct 2023
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K230418 is an FDA 510(k) clearance for the Mighty Wire Guide Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 28, 2023, 254 days after receiving the submission on February 16, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K230418 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2023
Decision Date October 28, 2023
Days to Decision 254 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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