510(k) K083814 ยท PDU Catheter For Crossing Total Occlusions
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
| Applicant | Cordis Corp., A Johnson & Johnson Co., Warren NJ, US |
| Decision | Substantially Equivalent, Jan 13, 2009 |
| Received | Dec 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083814
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.