510(k) K953963

RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION by Rusch, Inc. — Product Code BTS

K953963 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION". The FDA issued a decision of Substantially Equivalent on November 27, 1995. The device falls under product code BTS (Tube, Bronchial (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5720. Rusch, Inc. has at least 10 other 510(k) clearances on record.