FDA 510(k) Applications for Medical Device Product Code "DBY"
(Fab, Rhodamine, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K013919 BAYLIS MEDICAL CO., INC. TORFLEX TRANSSEPTAL GUIDING SHEATH 02/22/2002
K013304 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER 01/02/2002
K022067 BOSTON SCIENTIFIC CONVOY ADVANCED DELIVERY SHEATH 09/11/2002
K013866 BOSTON SCIENTIFIC CONVOY ADVANCED DELIVERY SHEATH KIT 12/14/2001
K771144 KENT LABORATORIES, INC. RHODAMINE-CONJUGATED ANTISERUM 07/14/1977
K013282 W. L. GORE & ASSOCIATES, INC. GORE INTRODUCER SHEATH 12/14/2001


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