510(k) K192684 ยท NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
HydroPearl Microspheres
| Applicant | MicroVention, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Jan 22, 2020 |
| Received | Sep 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192684
| 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.