510(k) K252674 ยท DQX Wire, Guide, Catheter
Solo Pace Fusion System (SOLOFUSE1)
| Applicant | Solo Pace, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Jan 9, 2026 |
| Received | Aug 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252674
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.