Cleared Traditional

CONCHASMART BREATHING CIRCUIT

K140556 · Teleflex, Inc. · Anesthesiology
Sep 2014
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K140556 is an FDA 510(k) clearance for the CONCHASMART BREATHING CIRCUIT, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Teleflex, Inc. (Durham, US). The FDA issued a Cleared decision on September 24, 2014, 203 days after receiving the submission on March 5, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K140556 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2014
Decision Date September 24, 2014
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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