Cleared Traditional

Glidesheath Slender

K173831 · Terumo Medical Corporation · Cardiovascular
May 2018
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K173831 is an FDA 510(k) clearance for the Glidesheath Slender, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on May 8, 2018, 141 days after receiving the submission on December 18, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K173831 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2017
Decision Date May 08, 2018
Days to Decision 141 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