510(k) K161552 ยท NGT Saline, Vascular Access Flush
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
| Applicant | Becton, Dickinson and Company, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Feb 2, 2017 |
| Received | Jun 6, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2024 | Becton Dickinson & Company PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547 Open, Classified |
NGT | None listed |
| Oct 14, 2019 | Becton Dickinson & Company BD Posiflush Pre-Filled Normal Saline Syringes
Catalog Number: 306547 Terminated |
NGT | None listed |
| Oct 14, 2019 | Becton Dickinson & Company BD Posiflush Pre-Filled Normal Saline Syringes
Catalog Number: 306575 (Canada only) Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.