510(k) K253063

Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) by Vitaltec Corporation — Product Code BTO

K253063 is an FDA 510(k) premarket notification submitted by Vitaltec Corporation for the device "Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Vitaltec Corporation has at least 2 other 510(k) clearances on record.