510(k) K964021 ยท HCG Device, Neurovascular Embolization
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
| Applicant | Baxter Edwards, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 27, 1997 |
| Received | Oct 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964021
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.