510(k) K053120 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
| Applicant | Excelsior Medical Corp., Neptune NJ, US |
| Decision | Substantially Equivalent, Dec 9, 2005 |
| Received | Nov 7, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2009 | Excelsior Medical Corp Sterile Field Saline Flush;
0.9% Sodium Chloride Injection, USP; Rx Only; Single Use.
Excelsior Medical, Neptune, NJ.
This product is used for the flushing of venous access devices and intravenous tu Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.