510(k) K260839 ยท DYB Introducer, Catheter
Protaryx Transseptal Puncture Device (PTX2-001)
| Applicant | Protaryx Medical, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Apr 10, 2026 |
| Received | Mar 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260839
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.