510(k) K993463 ยท FPA Set, Administration, Intravascular
INTRAVASCULAR ADMINISTRATION SET
| Applicant | Custom Assemblies, Inc., Mccordsville IN, US |
| Decision | Substantially Equivalent, Jan 4, 2000 |
| Received | Oct 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2021 | Stradis Medical, LLC dba Stradis Healthcare Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.