510(k) K103740 ยท NGT Saline, Vascular Access Flush
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
| Applicant | Spectra Medical Devices, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jul 29, 2011 |
| Received | Dec 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103740
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2026 | Spectra Medical Devices, Llc Brand Name: Elevaris/Spectra Medical Devices
Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule
Model/Catalog Number: AMPUL10MLK.
Sodium Chloride Flush for IV tubing systems and indwel Open, Classified |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.