510(k) K032298 ยท DQY Catheter, Percutaneous
MODIFICATION TO OUTBACK CATHETER
| Applicant | Lumend, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Aug 26, 2003 |
| Received | Jul 25, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032298
| 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 |
| Jul 20, 2004 | Lumend Inc LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas. Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.