510(k) K971608 ยท DYB Introducer, Catheter
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Jul 21, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2003 | Cordis Corporation Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only). Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.