510(k) K242863 ยท LDF Electrode, Pacemaker, Temporary
Bioptimal Bipolar Pacing Catheter
| Applicant | Bioptimal International Pte. , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Jun 15, 2025 |
| Received | Sep 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242863
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.