Cleared Traditional

Glidesheath Slender Tibial Pedal Kit

K181237 · Terumo Medical Corporation · Cardiovascular
Aug 2018
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K181237 is an FDA 510(k) clearance for the Glidesheath Slender Tibial Pedal Kit, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on August 3, 2018, 85 days after receiving the submission on May 10, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K181237 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2018
Decision Date August 03, 2018
Days to Decision 85 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