510(k) K113555 ยท NGT Saline, Vascular Access Flush
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
| Applicant | Am USA, Nashville TN, US |
| Decision | Substantially Equivalent, Jan 30, 2012 |
| Received | Dec 1, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2024 | MRP, LLC dba Aquabiliti AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syrin Open, Classified |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.