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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