510(k) K954584 ยท BSO Catheter, Conduction, Anesthetic
RACZ EPIDURAL CATHETER
| Applicant | Medic Evaluation Devices & Instruments Corp., Gloversville NY, US |
| Decision | Substantially Equivalent, Oct 8, 1996 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2021 | Epimed International, Inc. Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter
Catalog #: 157-1924
Intended for epidural anesthesia and is limited to placement of 72 hours or less Terminated |
BSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.