FDA 510(k) Applications Submitted by NAVILYST MEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K133264 |
10/23/2013 |
NMI PICC III |
NAVILYST MEDICAL, INC. |
| K140194 |
01/27/2014 |
NAMIC RCS SYRINGE |
NAVILYST MEDICAL, INC. |
| K140266 |
02/03/2014 |
NMI PICC IV |
NAVILYST MEDICAL, INC. |
| K150407 |
02/18/2015 |
BioFlo Midline Catheter |
NAVILYST MEDICAL, INC. |
| K131694 |
06/10/2013 |
NMI PORT II CATHETER |
NAVILYST MEDICAL, INC. |
| K093366 |
10/29/2009 |
NMI PICC II |
NAVILYST MEDICAL, INC. |
| K121089 |
04/10/2012 |
NMI PICC III |
NAVILYST MEDICAL, INC. |
| K131260 |
05/02/2013 |
NMI DIALYSIS CATHETER |
NAVILYST MEDICAL, INC. |
| K131942 |
06/27/2013 |
NMI PICC III CATHETER, NMI HPICC III CATHETER |
NAVILYST MEDICAL, INC. |
| K111906 |
07/05/2011 |
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY |
NAVILYST MEDICAL, INC. |
| K122767 |
09/10/2012 |
NMI PORT |
NAVILYST MEDICAL, INC. |
| K131038 |
04/15/2013 |
NMI PICC MAXIMAL BARRIER NURSING KITS |
NAVILYST MEDICAL, INC. |
| K121990 |
07/06/2012 |
PICC CONVENIENCE KIT |
NAVILYST MEDICAL, INC. |
| K113198 |
10/31/2011 |
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML |
NAVILYST MEDICAL, INC. |
| K132713 |
08/30/2013 |
NMI COAXIAL MICROINTRODUCER SET |
NAVILYST MEDICAL, INC. |
| K152069 |
07/27/2015 |
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter |
NAVILYST MEDICAL, INC. |
| K091261 |
04/29/2009 |
NMI PICC |
NAVILYST MEDICAL, INC. |
| K101326 |
05/11/2010 |
NMI IC |
NAVILYST MEDICAL, INC. |
| K151239 |
05/11/2015 |
NMI DUAL PORT II |
NAVILYST MEDICAL, INC. |
| K161866 |
07/07/2016 |
BioFlo Midline Catheter |
NAVILYST MEDICAL, INC. |
| K152409 |
08/26/2015 |
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC |
NAVILYST MEDICAL, INC. |
| K153228 |
11/06/2015 |
NMI Port, NMI Port II |
NAVILYST MEDICAL, INC. |
| K163452 |
12/09/2016 |
PICC Maximal Barrier Nursing Kit |
Navilyst Medical, Inc. |
| K091634 |
06/04/2009 |
NMI FC |
NAVILYST MEDICAL, INC. |
| K150448 |
02/20/2015 |
NMI PICC III and NMI PICC IV |
NAVILYST MEDICAL, INC. |
| K150527 |
03/02/2015 |
Xcela Power Injectable PICC |
NAVILYST MEDICAL, INC. |
| K111315 |
05/10/2011 |
MULTIPURPOSE DRAINAGE CATHETER |
NAVILYST MEDICAL, INC. |
| K121954 |
07/03/2012 |
NMI MICROCATHETER |
NAVILYST MEDICAL, INC. |
| K112124 |
07/25/2011 |
MICROCATHETER |
NAVILYST MEDICAL, INC. |
| K122882 |
09/20/2012 |
NMI HPICC III |
NAVILYST MEDICAL, INC. |
| K093392 |
10/30/2009 |
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS |
NAVILYST MEDICAL, INC. |
| K123445 |
11/08/2012 |
NMI COAXIAL MICROINTRODUCER SET |
NAVILYST MEDICAL, INC. |
| K103353 |
11/16/2010 |
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER |
NAVILYST MEDICAL, INC. |
| K113638 |
12/09/2011 |
NMI 2.8 MICROCATHETER |
NAVILYST MEDICAL, INC. |
| K142616 |
09/16/2014 |
PICC Maximal Barrier Nursing Kit |
NAVILYST MEDICAL, INC. |
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