510(k) K042297 ยท HCG Device, Neurovascular Embolization
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
| Applicant | Acta Vascular Systems, Inc., Los Gatos CA, US |
| Decision | Substantially Equivalent, Jun 1, 2005 |
| Received | Aug 24, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042297
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.