510(k) K233713

Pilling Tracheostomy Tubes by Teleflex Medical — Product Code BTO

K233713 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Pilling Tracheostomy Tubes". The FDA issued a decision of Substantially Equivalent on March 22, 2024. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Teleflex Medical has at least 10 other 510(k) clearances on record.