510(k) K150836 ยท PDU Catheter For Crossing Total Occlusions
OUTBACK Elite Re-Entry Catheter
| Applicant | Cordis Corporation, A Johnson & Johnson Co., Fremont CA, US |
| Decision | Substantially Equivalent, Apr 29, 2015 |
| Received | Mar 30, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150836
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.