Cleared Traditional

TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470

K051587 · Tracoe Medical GmbH · Anesthesiology
Oct 2005
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K051587 is an FDA 510(k) clearance for the TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Tracoe Medical GmbH (Westborough, US). The FDA issued a Cleared decision on October 25, 2005, 132 days after receiving the submission on June 15, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K051587 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2005
Decision Date October 25, 2005
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTO — Tube, Tracheostomy (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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