510(k) K250529 ยท DRA Catheter, Steerable
Globe Introducer (601-01001)
| Applicant | Kardium, Inc., Burnaby, CA |
| Decision | Substantially Equivalent, Jun 3, 2025 |
| Received | Feb 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250529
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.