Cleared Traditional

Sheridan Endobronchial Tubes

K180253 · Teleflex Medical · Anesthesiology

Nov 2018

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K180253 is an FDA 510(k) clearance for the Sheridan Endobronchial Tubes, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on November 2, 2018, 276 days after receiving the submission on January 30, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K180253 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2018
Decision Date	November 02, 2018
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5740