510(k) K202874

Puritan Bennett Cuff Pressure Manager by Covidien, LLC — Product Code BSK

K202874 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Puritan Bennett Cuff Pressure Manager". The FDA issued a decision of Substantially Equivalent on January 9, 2021. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Covidien, LLC has at least 10 other 510(k) clearances on record.