Company
Navilyst Medical, Inc., an AngioDyamics Company
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
23recalls (0 in 12 months)
23recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 23 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PI Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PI Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wit Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wi Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV an Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybr Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid P Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PA Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wit Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wit Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are in Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY
The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are i Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980
The Vaxcel PICC with PASV is indicated for use in estab Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY
The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous s Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY
The Vaxcel PICC w Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY.
The Vaxcel PICC with PASV Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY
The Vaxcel PICC with PASV is indicated for Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY.
The Vaxcel PICC with PASV is indicated for use in establishing periphe Terminated |
LJS | K021704 |
| Mar 14, 2016 | Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY.
The Vaxcel PICC with PASV is indicated f Terminated |
LJS | K021704 |