510(k) K150870 ยท KRD Device, Vascular, For Promoting Embolization
HydroPearl Microspheres, HydroPearl Microspheres
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Dec 21, 2015 |
| Received | Apr 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150870
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | MICROVENTION INC. TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 Open, Classified |
NOY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.