Medical Device Manufacturer · US , Marlborough , MA

Navilyst Medical, Inc. - FDA 510(k) Cleared Devices

35 submissions · 33 cleared · Since 2009
35
Total
33
Cleared
0
Denied

FDA 510(k) Regulatory Record - Navilyst Medical, Inc. General Hospital

23 devices
1-23 of 23
Cleared Feb 03, 2017
PICC Maximal Barrier Nursing Kit
K163452 · LJS
General Hospital · 56d
Cleared Sep 08, 2016
BioFlo Midline Catheter
K161866 · FOZ
General Hospital · 63d
Cleared Jun 06, 2016
NMI DUAL PORT II
K151239 · LJT
General Hospital · 392d
Cleared Dec 04, 2015
NMI Port, NMI Port II
K153228 · LJT
General Hospital · 28d
Cleared Sep 24, 2015
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · LJS
General Hospital · 29d
Cleared May 15, 2015
BioFlo Midline Catheter
K150407 · FOZ
General Hospital · 86d
Cleared Mar 31, 2015
Xcela Power Injectable PICC
K150527 · LJS
General Hospital · 29d
Cleared Mar 19, 2015
NMI PICC III and NMI PICC IV
K150448 · LJS
General Hospital · 27d
Cleared Oct 14, 2014
PICC Maximal Barrier Nursing Kit
K142616 · LJS
General Hospital · 28d
Cleared Apr 14, 2014
NAMIC RCS SYRINGE
K140194 · FMF
General Hospital · 77d
Cleared Mar 05, 2014
NMI PICC IV
K140266 · LJS
General Hospital · 30d
Cleared Nov 20, 2013
NMI PICC III
K133264 · LJS
General Hospital · 28d
Cleared Aug 08, 2013
NMI PORT II CATHETER
K131694 · LJT
General Hospital · 59d
Cleared Jul 31, 2013
NMI PICC III CATHETER, NMI HPICC III CATHETER
K131942 · LJS
General Hospital · 34d
Cleared May 09, 2013
NMI PICC MAXIMAL BARRIER NURSING KITS
K131038 · LJS
General Hospital · 24d
Cleared Apr 30, 2013
NMI PORT
K122767 · LJT
General Hospital · 232d
Cleared Oct 18, 2012
NMI HPICC III
K122882 · LJS
General Hospital · 28d
Cleared Aug 23, 2012
NMI PICC III
K121089 · LJS
General Hospital · 135d
Cleared Aug 03, 2012
PICC CONVENIENCE KIT
K121990 · LJS
General Hospital · 28d
Cleared Jul 29, 2011
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
K111906 · LJS
General Hospital · 24d
Cleared Sep 02, 2010
NMI IC
K101326 · LJS
General Hospital · 114d
Cleared Nov 24, 2009
NMI PICC II
K093366 · LJS
General Hospital · 26d
Cleared May 12, 2009
NMI PICC
K091261 · LJS
General Hospital · 13d
Filters