510(k) K251358 ยท MJN Catheter, Intravascular Occluding, Temporary
Bridge Plus Occlusion Balloon (590-002)
| Applicant | Philips Image Guided Therapy Devices, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jun 24, 2025 |
| Received | Apr 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251358
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.