510(k) K152409 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Sep 24, 2015 |
| Received | Aug 26, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152409
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 Terminated |
LJS | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL XCELA PICC, Catalog Number 60M122272 Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.