Cleared Traditional

D'Vill Introducer

K171206 · NuMED, Inc. · Cardiovascular
Oct 2017
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K171206 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 October 20, 2017, 178 days after receiving the submission on April 25, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K171206 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2017
Decision Date October 20, 2017
Days to Decision 178 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