510(k) K043581 ยท EYB Catheter, Ureteral, Gastro-Urology
DUAL LUMEN CATHETER
| Applicant | Acmi Corporation, Southborough MA, US |
| Decision | Substantially Equivalent, Mar 3, 2005 |
| Received | Dec 28, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Gyrus ACMI Corporation Gyrus ACMI 10 Fr. Dual Lumen Catheter
Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, Terminated |
EYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.