510(k) K133685 ยท NGT Saline, Vascular Access Flush
0.9% SODIUM CHLORIDE FLUSH SYRINGE
| Applicant | Am USA, Nashville TN, US |
| Decision | Substantially Equivalent, Aug 13, 2014 |
| Received | Dec 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2015 | MRP, LLC dba AMUSA 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806
Usage: Flush syringe. Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.