510(k) K831087 ยท FPA Set, Administration, Intravascular
MINI-VOL EXTENSION SET
| Applicant | Beech Medical, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 28, 1983 |
| Received | Apr 4, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2015 | Smiths Medical Asd Inc Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.