510(k) K233341

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) by Covidien, LLC — Product Code BTR

K233341 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)". The FDA issued a decision of Substantially Equivalent on May 20, 2024. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Covidien, LLC has at least 10 other 510(k) clearances on record.