510(k) K831751 ยท DYB Introducer, Catheter
LEAD INTRODUCER SETS-EB-S8 & EB-S12
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Oct 20, 1983 |
| Received | Jun 1, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831751
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2005 | Guidant Corporation Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.