510(k) K142616 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PICC Maximal Barrier Nursing Kit
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Oct 14, 2014 |
| Received | Sep 16, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PICC, Catalog Number 60M071831 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) 5F DL BIOFLO PICC, Catalog Number 60M180592 Terminated |
LJS | None listed |
| Aug 29, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Xcela Power Injectable PICC Maximal Barrier Nursing Kit
The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is i Terminated |
LJS | None listed |
| Aug 29, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit -
1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H96 Terminated |
LJS | None listed |
| Aug 29, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019
The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or lon Terminated |
LJS | None listed |
| Jun 8, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014
The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo Terminated |
LJS | None listed |
| Jun 8, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019
The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFl Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.