Cleared Special

D'Vill Introducer

K190974 · NuMED, Inc. · Cardiovascular
May 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K190974 is an FDA 510(k) clearance for the D'Vill Introducer, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on May 14, 2019, 29 days after receiving the submission on April 15, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K190974 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2019
Decision Date May 14, 2019
Days to Decision 29 days
Submission Type Special
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