510(k) K221163 ยท PDU Catheter For Crossing Total Occlusions
Tunnel Crossing Catheter
| Applicant | Tractus Vascular, LLC, Eatontown NJ, US |
| Decision | Substantially Equivalent, Jan 19, 2023 |
| Received | Apr 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221163
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.