510(k) K161866 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
BioFlo Midline Catheter
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Sep 8, 2016 |
| Received | Jul 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490 Terminated |
FOZ | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810 Terminated |
FOZ | None listed |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.