510(k) K150448 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
NMI PICC III and NMI PICC IV
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Mar 19, 2015 |
| Received | Feb 20, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150448
| 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 with Nitinol GW PG, Catalog Number 45-882 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M132324 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) 5F DL BIOFLO PASV, Catalog Number 60M141006 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M150373 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M161567 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M181578 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M183481 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indi Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indi Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are i Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are i Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are i Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technolog Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technolog Terminated |
LJS | None listed |
| Nov 28, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895
The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technolog Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.