FDA 510(k) Applications Submitted by LAURIE LEWANDOWSKI
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100169 |
01/20/2010 |
DURASPAN HEMODIALYSIS LONG-TERM CATHETER |
R4 VASCULAR, INC. |
| K131329 |
05/08/2013 |
VECTOR PTA BALLOON DILATATION CATHETER |
R4 VASCULAR, INC. |
| K091506 |
05/21/2009 |
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 |
R4 VASCULAR, INC. |
| K181420 |
05/31/2018 |
Aequalis Flex Revive Shoulder System |
Tornier, Inc. |
| K161742 |
06/24/2016 |
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid |
Tornier, Inc. |
| K092040 |
07/02/2009 |
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 |
R4 VASCULAR, INC. |
| K162440 |
08/31/2016 |
CardioInsight Cardiac Mapping System |
CARDIOINSIGHT TECHNOLOGIES, INC |
| K083763 |
12/18/2008 |
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN |
R4 VASCULAR, INC. |
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