510(k) K041983 ยท EZL Catheter, Retention Type, Balloon
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
| Applicant | Opticon Medical, Dublin OH, US |
| Decision | Substantially Equivalent, Nov 17, 2004 |
| Received | Jul 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041983
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2016 | C.R. Bard, Inc. Option-vm Urinary Catheter. Male 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.