FDA 510(k) Applications Submitted by Balaka Das

FDA 510(k) Number Submission Date Device Name Applicant
K090017 01/02/2009 CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES BIOSENSE WEBSTER, INC.
K090120 01/21/2009 REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 BIOSENSE WEBSTER, INC.
K080425 02/15/2008 CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 BIOSENSE WEBSTER, INC.
K091352 05/07/2009 SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 BIOSENSE WEBSTER, INC.
K101345 05/13/2010 WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, BIOSENSE WEBSTER, INC.
K101991 07/14/2010 WEBSTER DUO-DECAPOLAR CATHETER BIOSENSE WEBSTER, INC.
K093455 11/05/2009 CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES BIOSENSE WEBSTER, INC.


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