510(k) K252792 · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PM2 System with ECGuide Connector
| Applicant | Piccolo Medical, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Nov 17, 2025 |
| Received | Sep 2, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252792
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.