The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydropearl Microspheres.
| Device ID | K192684 |
| 510k Number | K192684 |
| Device Name: | HydroPearl Microspheres |
| Classification | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia |
| Applicant | MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Contact | Analia Staubly |
| Correspondent | Analia Staubly MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Product Code | NOY |
| Subsequent Product Code | KRD |
| Subsequent Product Code | NAJ |
| CFR Regulation Number | 876.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-01-22 |