510(k) K100283

VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC by Cook, Inc. — Product Code BTO

K100283 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC". The FDA issued a decision of Substantially Equivalent on April 23, 2010. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Cook, Inc. has at least 10 other 510(k) clearances on record.