510(k) K223130

Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) by Covidien — Product Code BTR

K223130 is an FDA 510(k) premarket notification submitted by Covidien for the device "Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)". The FDA issued a decision of Substantially Equivalent on August 30, 2023. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Covidien has at least 10 other 510(k) clearances on record.