510(k) K243432 ยท OWB Interventional Fluoroscopic X-Ray System
Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Jul 22, 2025 |
| Received | Nov 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243432
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.