510(k) K945616 ยท DYB Introducer, Catheter
CORDIS AVANTI CATHETER SHEATH INTRODUCER
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Mar 29, 1995 |
| Received | Nov 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2010 | Cordis Corporation Cordis, AVANTI+ Introducer, STERILE EO, For one use only.
Catalog 402656X Lot # 15076369.
Catalog 504606X Lot # 15075717.
Catalog 504656X Lot # 15076362, 15076363, 15076364. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.