The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Lifepearl Microshperes.
| Device ID | K150958 |
| 510k Number | K150958 |
| Device Name: | LifePearl Microshperes |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MicroVention, Inc. 1311 Valencia Ave. Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MicroVention, Inc. 1311 Valencia Ave. Tustin, CA 92780 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-09 |
| Decision Date | 2015-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812636022147 | K150958 | 000 |
| 00812636022130 | K150958 | 000 |
| 00812636022123 | K150958 | 000 |