510(k) K121050 ยท NGT Saline, Vascular Access Flush
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
| Applicant | Becton, Dickinson & CO, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Feb 7, 2013 |
| Received | Apr 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2014 | Becton Dickinson & Company BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553.
Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Sal Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.