510(k) K981329 ยท BSO Catheter, Conduction, Anesthetic
FETH-R-KATH
| Applicant | Epimed International, Inc., Gloversville NY, US |
| Decision | Substantially Equivalent, Aug 26, 1998 |
| Received | Apr 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2017 | Epimed International NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile Completed |
BSO | None listed |
| Dec 28, 2017 | Epimed International NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile Completed |
BSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.