510(k) K863606 ยท FMI Needle, Hypodermic, Single Lumen
BUTTERFLY NON-CORING NEEDLE SET
| Applicant | Cormed, Inc., Sub. C.R.Bard, Inc., Medina NY, US |
| Decision | Substantially Equivalent, Dec 18, 1986 |
| Received | Sep 16, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2003 | Bard Access Systems, Inc Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic. Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.