510(k) K023090 ยท EZL Catheter, Retention Type, Balloon
OPTION-VF URINARY CATHETER, FV14218
| Applicant | Opticon Medical, Inc., Dublin OH, US |
| Decision | Substantially Equivalent, Mar 19, 2003 |
| Received | Sep 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2016 | C.R. Bard, Inc. Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. Terminated |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.