510(k) K253799 ยท DXF Catheter, Septostomy
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
| Applicant | Pressure Products Medical Device Manufacturing, LLC, Morton PA, US |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Nov 28, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253799
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.