FDA 510(k) Applications Submitted by WANDA CARPINELLA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K142593 |
09/15/2014 |
AngioVac Cannula |
AngioDynamics, 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. |
| K974640 |
12/15/1997 |
COAXIAL DILATOR SET |
BOSTON SCIENTIFIC CORP. |
| K980566 |
02/13/1998 |
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER |
BOSTON SCIENTIFIC CORP. |
| K971165 |
03/31/1997 |
INTRODUCER SHEATH AND DILATOR |
BOSTON SCIENTIFIC CORP. |
| K953750 |
08/10/1995 |
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
BOSTON SCIENTIFIC CORP. |
| K973645 |
09/24/1997 |
RENEGADE FIBER BRAIDED MICROCATHETER |
BOSTON SCIENTIFIC CORP. |
| K954651 |
10/10/1995 |
ELECTRODE RECORDING CATHETER |
BOSTON SCIENTIFIC CORP. |
| K964538 |
11/12/1996 |
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM |
BOSTON SCIENTIFIC CORP. |
| K955587 |
12/07/1995 |
VASCULAR ACCESS PORT KIT |
BOSTON SCIENTIFIC CORP. |
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