Cleared Traditional

VSI Micro-Introducer Kit

K180913 · Vascular Solutions, Inc. · Cardiovascular
May 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K180913 is an FDA 510(k) clearance for the VSI Micro-Introducer Kit, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on May 9, 2018, 30 days after receiving the submission on April 9, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K180913 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2018
Decision Date May 09, 2018
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340