510(k) K210839 ยท PDU Catheter For Crossing Total Occlusions
SoundBite Crossing System - Peripheral (14P)
| Applicant | Soundbite Medical Solutions, Inc., Montreal, CA |
| Decision | Substantially Equivalent, Apr 20, 2021 |
| Received | Mar 22, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210839
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.