510(k) K043534 ยท DQY Catheter, Percutaneous
MODIFICATION TO OUTBACK CATHETER
| Applicant | Lumend, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 21, 2005 |
| Received | Dec 22, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043534
| 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.