FDA 510(k) Applications Submitted by KAREN J MCKELVEY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K051840 |
07/07/2005 |
ENSITE VERISMO SOFTWARE |
ST. JUDE MEDICAL |
| K083328 |
11/12/2008 |
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 |
ST. JUDE MEDICAL |
| K030129 |
01/14/2003 |
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
| K080292 |
02/04/2008 |
EPICOR ABLATION SYSTEM |
ST. JUDE MEDICAL |
| K070902 |
04/02/2007 |
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 |
ST. JUDE MEDICAL |
| K060954 |
04/07/2006 |
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 |
ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS |
| K071818 |
07/03/2007 |
ENSITE FUSION DYNAMIC REGISTRATION TOOL |
ST. JUDE MEDICAL |
| K082467 |
08/27/2008 |
ENSITE FUSION DYNAMIC REGISTRATION TOOL |
ST. JUDE MEDICAL |
| K042493 |
09/14/2004 |
ENSITE SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
| K033211 |
10/03/2003 |
ENSITE SYSTEM |
ENDOCARDIAL SOLUTIONS, INC. |
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