510(k) K142620 ยท NGT Saline, Vascular Access Flush
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
| Applicant | Excelsior Medical Corporation, Neptune NJ, US |
| Decision | Substantially Equivalent, Dec 12, 2014 |
| Received | Sep 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2018 | Medline Industries Inc Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR
Intended for flushing IV catheters and IV tubing only. Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.