FDA 510(k) Applications for Medical Device Product Code "BTS"
(Tube, Bronchial (W/Wo Connector))

FDA 510(k) Number Applicant Device Name Decision Date
K912290 BOSTON MEDICAL PRODUCTS, INC. HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)) 08/26/1991
K902116 CONCORD/PORTEX MODIFIED ENDOBRONCHIAL TUBE 08/03/1990
K771219 MALLINCKRODT CRITICAL CARE BRONCHO-CATH 08/04/1977
K834565 PORTEX, INC. ENDOBRONCHIAL TWIN LUMEN TUBE 01/17/1984
K951091 RUSCH INTL. RUSCH ENDOBRONCHIAL TUBE SETS 06/08/1995
K953963 RUSCH, INC. RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION 11/27/1995
K833297 SURGITEK BRONCHOSCOPY TUBE W/ULTRA LOCUFF 12/27/1983


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