510(k) K230159 · PDU Catheter For Crossing Total Occlusions
SoundBite® Crossing System XS Peripheral
| Applicant | Soundbite Medical Solutions, Inc., Montreal, CA |
| Decision | Substantially Equivalent, Aug 28, 2023 |
| Received | Jan 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230159
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.