Cleared Traditional

RAILWAY Sheathless Access System

K180081 · Cordis Corporation · Cardiovascular
Apr 2018
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K180081 is an FDA 510(k) clearance for the RAILWAY Sheathless Access System, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Cordis Corporation (Milpitas, US). The FDA issued a Cleared decision on April 18, 2018, 97 days after receiving the submission on January 11, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K180081 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2018
Decision Date April 18, 2018
Days to Decision 97 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