510(k) K884494 ยท DYB Introducer, Catheter
DAIG OBTURATOR, CATHETER INTRODUCER
| Applicant | Daig Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 22, 1989 |
| Received | Oct 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2005 | St. Jude Medical / Daig Division Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.