510(k) K860484 ยท KOD Catheter, Urological
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
| Applicant | The Kendal Co., Boston MA, US |
| Decision | Substantially Equivalent, Mar 11, 1986 |
| Received | Feb 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | Cardinal Health 200, LLC Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE Open, Classified |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.