510(k) K183399 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
BD Nexiva Closed IV Catheter System
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Mar 20, 2019 |
| Received | Dec 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2022 | Becton Dickinson Infusion Therapy Systems Inc. BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr) Open, Classified |
FOZ | None listed |
| Sep 8, 2021 | Becton Dickinson Infusion Therapy Systems Inc. BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Open, Classified |
FOZ | None listed |
| Sep 14, 2020 | Becton Dickinson & Company BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN)
Catalog (Ref) No. 383538
BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short te Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.