510(k) K161777 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Aug 29, 2016 |
| Received | Jun 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2019 | Becton Dickinson & Company BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system
Catalog Number: 383536 Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.