510(k) K192211 ยท PDU Catheter For Crossing Total Occlusions
SoundBite Console, SoundBite Active Wire 18
| Applicant | Soundbite Medical Solution, Inc., Montreal, CA |
| Decision | Substantially Equivalent, Jan 17, 2020 |
| Received | Aug 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192211
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.