510(k) K050600 ยท FPA Set, Administration, Intravascular
MINILOC SAFETY INFUSION SET
| Applicant | Specialized Health Products, Intl., Bountiful UT, US |
| Decision | Substantially Equivalent, May 12, 2005 |
| Received | Mar 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050600
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2017 | Bard Access Systems MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc trays per case and 160 per carton.
Product U Terminated |
FPA | None listed |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.