510(k) K163452 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PICC Maximal Barrier Nursing Kit
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Unknown, Feb 3, 2017 |
| Received | Dec 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038 Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.