Company ยท US
Navilyst Medical, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2017. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
92recalls (0 in 12 months)
31recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OEZ | Cardiovascular Procedure Kit | 54 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 28 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 18 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 |
| OEQ | Angiography/Angioplasty Kit | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DXT | Injector And Syringe, Angiographic | 1 |
| FMF | Syringe, Piston | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 3, 2017 | K163452 | PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc. | LJS |
| Sep 8, 2016 | K161866 | BioFlo Midline Catheter Navilyst Medical, Inc. | FOZ |
| Jun 6, 2016 | K151239 | NMI DUAL PORT II Navilyst Medical, Inc. | LJT |
| Dec 4, 2015 | K153228 | NMI Port, NMI Port II Navilyst Medical, Inc. | LJT |
| Sep 24, 2015 | K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC Navilyst Medical, Inc. | LJS |
| Sep 24, 2015 | K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainag Navilyst Medical, Inc. | FGE |
| May 15, 2015 | K150407 | BioFlo Midline Catheter Navilyst Medical, Inc. | FOZ |
| Mar 31, 2015 | K150527 | Xcela Power Injectable PICC Navilyst Medical, Inc. | LJS |
| Mar 19, 2015 | K150448 | NMI PICC III and NMI PICC IV Navilyst Medical, Inc. | LJS |
| Oct 14, 2014 | K142616 | PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc. | LJS |
| Apr 14, 2014 | K140194 | NAMIC RCS SYRINGE Navilyst Medical, Inc. | FMF |
| Mar 5, 2014 | K140266 | NMI PICC IV Navilyst Medical, Inc. | LJS |
| Feb 14, 2014 | K131260 | NMI DIALYSIS CATHETER Navilyst Medical, Inc. | MSD |
| Nov 20, 2013 | K133264 | NMI PICC III Navilyst Medical, Inc. | LJS |
| Sep 27, 2013 | K132713 | NMI COAXIAL MICROINTRODUCER SET Navilyst Medical, Inc. | DRE |
| Aug 8, 2013 | K131694 | NMI PORT II CATHETER Navilyst Medical, Inc. | LJT |
| Jul 31, 2013 | K131942 | NMI PICC III CATHETER, NMI HPICC III CATHETER Navilyst Medical, Inc. | LJS |
| May 9, 2013 | K131038 | NMI PICC MAXIMAL BARRIER NURSING KITS Navilyst Medical, Inc. | LJS |
| Apr 30, 2013 | K122767 | NMI PORT Navilyst Medical, Inc. | LJT |
| Apr 1, 2013 | K123445 | NMI COAXIAL MICROINTRODUCER SET Navilyst Medical, Inc. | DRE |
| Oct 18, 2012 | K122882 | NMI HPICC III Navilyst Medical, Inc. | LJS |
| Aug 23, 2012 | K121089 | NMI PICC III Navilyst Medical, Inc. | LJS |
| Aug 3, 2012 | K121990 | PICC CONVENIENCE KIT Navilyst Medical, Inc. | LJS |
| Jul 17, 2012 | K121954 | NMI MICROCATHETER Navilyst Medical, Inc. | DQO |
| Jan 5, 2012 | K113638 | NMI 2.8 MICROCATHETER Navilyst Medical, Inc. | DQO |
| Nov 28, 2011 | K113198 | NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML Navilyst Medical, Inc. | DXT |
| Aug 19, 2011 | K112124 | MICROCATHETER Navilyst Medical, Inc. | DQO |
| Jul 29, 2011 | K111906 | XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY Navilyst Medical, Inc. | LJS |
| Jun 8, 2011 | K111315 | MULTIPURPOSE DRAINAGE CATHETER Navilyst Medical, Inc. | FGE |
| Jan 14, 2011 | K103353 | MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER Navilyst Medical, Inc. | FGE |
| Sep 2, 2010 | K101326 | NMI IC Navilyst Medical, Inc. | LJS |
| Mar 1, 2010 | K091634 | NMI FC Navilyst Medical, Inc. | DTL |
| Dec 31, 2009 | K093392 | MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS Navilyst Medical, Inc. | FGE |
| Nov 24, 2009 | K093366 | NMI PICC II Navilyst Medical, Inc. | LJS |
| May 12, 2009 | K091261 | NMI PICC Navilyst Medical, Inc. | LJS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683.
NAMIC Convenience Kits are intended to b Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE, Rx ONLY ---For single use only. Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STERILE, Rx ONLY - For single use only. --- Device Listing Number D136588
NAMIC C Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to b Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to b Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 60041632, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683.
NAMIC Convenience Kits are Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212, STERILE, Rx ONLY --- For single use only. ---Device Listing Number D136588.
NAMIC Convenience Kits are intended Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 60200057, STERILE, Rx ONLY --- For single use only.
--- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intend Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits a Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kit Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683.
Product Usage:
NAMIC Convenience Kits are Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 60111311, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683.
Product Usage:
NAMIC Convenience Kits Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenie Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For single use only. ---Device Listing Number D136588.
Product Usage:
NAMIC Convenienc Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits ar Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kit Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683.
Product Usage:
NAMIC Convenience Kits ar Terminated |
OEQ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Ki Terminated |
OEZ | None listed |
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