Cleared Traditional

RUSCH ENDOBRONCHIAL TUBES

K141888 · Teleflexmedical, Inc. · Anesthesiology

Apr 2015

Decision

275d

Days

Class 2

Risk

About This 510(k) Submission

K141888 is an FDA 510(k) clearance for the RUSCH ENDOBRONCHIAL TUBES, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on April 15, 2015, 275 days after receiving the submission on July 14, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K141888 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2014
Decision Date	April 15, 2015
Days to Decision	275 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