510(k) K082689 ยท NGT Saline, Vascular Access Flush
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
| Applicant | Spectra Medical Devices, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Mar 20, 2009 |
| Received | Sep 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082689
| 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.