Cleared Traditional

Puritan Bennett Cuff Pressure Manager

K202874 · Covidien, LLC · Anesthesiology
Jan 2021
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K202874 is an FDA 510(k) clearance for the Puritan Bennett Cuff Pressure Manager, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Covidien, LLC (Shanghai, CN). The FDA issued a Cleared decision on January 9, 2021, 103 days after receiving the submission on September 28, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K202874 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2020
Decision Date January 09, 2021
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750

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