510(k) K092938 ยท NZW Heparin, Vascular Access Flush
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
| Applicant | App Pharmaceuticals, LLC, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Jun 18, 2010 |
| Received | Sep 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2015 | Fresenius Kabi USA, LLC HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710 Terminated |
NZW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.