FDA 510(k) Applications Submitted by Nichelle LaFlesh
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160598 |
03/02/2016 |
REBOA Balloon Catheter |
NUMED, INC. |
| K110903 |
03/31/2011 |
PTS-X SIZING BALLOON CATHETER |
NUMED, INC. |
| K160889 |
03/31/2016 |
BIB Stent Placement Catheter |
NUMED, INC. |
| K190974 |
04/15/2019 |
D'Vill Introducer |
NuMED, Inc. |
| K211134 |
04/16/2021 |
BIB Stent Placement Catheter |
NuMED, Inc |
| K171206 |
04/25/2017 |
D'Vill Introducer |
NuMED, Inc. |
| K041093 |
04/27/2004 |
NUMED MULLINS X PTA CATHETER |
NUMED, INC. |
| K041306 |
05/17/2004 |
NUMED PTS X SIZING BALLOON CATHETER |
NUMED, INC. |
| K051343 |
05/23/2005 |
MINI GHOST PTA CATHETER, MODEL 507 |
NUMED, INC. |
| K161451 |
05/26/2016 |
BIB Stent Placement Catheter |
NUMED, INC. |
| K991977 |
06/11/1999 |
TYSHAK, MODEL 102 AND Z-MED, MODEL 302 |
NUMED, INC. |
| K001804 |
06/15/2000 |
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER |
NUMED, INC. |
| K081680 |
06/17/2008 |
NUCLEUS-X, MODEL 230X |
NUMED, INC. |
| K211910 |
06/21/2021 |
Z-6 Atrioseptostomy Catheter |
NuMED, Inc. |
| K131869 |
06/24/2013 |
PTS-X SIZING BALLOON CATHETER |
NUMED, INC. |
| K121859 |
06/26/2012 |
TYSHAK NUCLEUS |
NUMED, INC. |
| K122012 |
07/10/2012 |
Z-MED Z-MED II |
NUMED, INC. |
| K102473 |
08/30/2010 |
MULLINS-X PTV CATHETER |
NUMED, INC. |
| K082524 |
09/02/2008 |
MINI GHOST, MODEL: 507 |
NUMED, INC. |
| K082868 |
09/29/2008 |
MULLINS-X, MODEL 250X |
NUMED, INC. |
| K003320 |
10/24/2000 |
PTA-OS SIZING BALLOON, MODEL 360 |
NUMED, INC. |
| K003643 |
11/27/2000 |
NUMED Z-MED PTV CATHERERS |
NUMED, INC. |
| K213915 |
12/15/2021 |
BIB Stent Placement Catheter |
NuMED Inc. |
| DEN080015 |
12/24/2008 |
NUCLEUS-X PTV CATHETER |
NUMED, INC. |
| K030589 |
02/25/2003 |
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
NUMED, INC. |
| K010880 |
03/23/2001 |
NUMED HIGH PRESSURE PTA CATHETERS |
NUMED, INC. |
| K040830 |
03/31/2004 |
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
NUMED, INC. |
| K011557 |
05/21/2001 |
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
NUMED, INC. |
| K022722 |
08/16/2002 |
PTA AND PTV |
NUMED, INC. |
| K032591 |
08/22/2003 |
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER |
NUMED, INC. |
| K003052 |
10/02/2000 |
NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
NUMED, INC. |
| K003114 |
10/05/2000 |
NUMED TYSHAK AND Z-MED PTV CATHETERS |
NUMED, INC. |
| K003276 |
10/19/2000 |
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 |
NUMED, INC. |
| K013601 |
10/31/2001 |
NUMED MULLINS PTA CATHETER |
NUMED, INC. |
| K003902 |
12/19/2000 |
MULTITRACK ANGIOGRAPHIC CATHETER |
NUMED, INC. |
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