510(k) K001577 ยท DQY Catheter, Percutaneous
OUTBACK CATHETER
| Applicant | Lumend, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 11, 2001 |
| Received | May 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001577
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2008 | Cordis Corporation Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The can Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.