510(k) K150958 ยท KRD Device, Vascular, For Promoting Embolization
LifePearl Microshperes
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Sep 17, 2015 |
| Received | Apr 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150958
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2025 | MICROVENTION INC. LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400 Open, Classified |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.