510(k) K073050 ยท FPA Set, Administration, Intravascular
SAFESTEP MAX POWER-INJECTABLE INFUSION SET
| Applicant | Specialized Health Products International, Inc., Bountiful UT, US |
| Decision | Substantially Equivalent, Jan 25, 2008 |
| Received | Oct 29, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2015 | Bard Access Systems PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215
The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling thro 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.