510(k) K970485 ยท FPA Set, Administration, Intravascular
SMARTSITE ACCESS PIN
| Applicant | Ivac Medical Systems, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Feb 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2021 | CAREFUSION BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E Open, Classified |
FPA | None listed |
| Aug 2, 2021 | CAREFUSION BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006 Open, Classified |
FPA | None listed |
| Nov 17, 2016 | CareFusion 303, Inc. SmartSite Add-On Bag Access Device, Model No. 10013365 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.