510(k) K131914 ยท PDU Catheter For Crossing Total Occlusions
OFFROAD RE-ENTRY CATHETER SYSTEM
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 31, 2013 |
| Received | Jun 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131914
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.