510(k) K260289 ยท DQY Catheter, Percutaneous
Perfect-O Ostial Positioning Catheter
| Applicant | Balosmark, Inc., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Jun 5, 2026 |
| Received | Jan 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260289
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.