510(k) K183357 ยท PDU Catheter For Crossing Total Occlusions
XableCath Crossing Catheter
| Applicant | Xablecath, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 21, 2019 |
| Received | Dec 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183357
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.