Cleared Traditional

MC3 Vascular Access Kit 21030

K182914 · Mc3 Incorporated · Cardiovascular
Oct 2018
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K182914 is an FDA 510(k) clearance for the MC3 Vascular Access Kit 21030, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Mc3 Incorporated (Dexter, US). The FDA issued a Cleared decision on October 29, 2018, 11 days after receiving the submission on October 18, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K182914 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2018
Decision Date October 29, 2018
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRE — Dilator, Vessel, For Percutaneous Catheterization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1310

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