510(k) K193012 ยท DQY Catheter, Percutaneous
speX Support Catheter
| Applicant | Reflow Medical, San Clemente CA, US |
| Decision | Substantially Equivalent, Feb 19, 2020 |
| Received | Oct 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193012
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.