The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydropearl Microspheres, Hydropearl Microspheres.
| Device ID | K150870 |
| 510k Number | K150870 |
| Device Name: | HydroPearl Microspheres, HydroPearl Microspheres |
| 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 | 2015-04-01 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812636020655 | K150870 | 000 |
| 00816777026088 | K150870 | 000 |
| 00816777026095 | K150870 | 000 |
| 00816777026101 | K150870 | 000 |
| 00816777026118 | K150870 | 000 |
| 00816777026125 | K150870 | 000 |
| 00816777026132 | K150870 | 000 |
| 00812636020617 | K150870 | 000 |
| 00812636020624 | K150870 | 000 |
| 00812636020631 | K150870 | 000 |
| 00812636020648 | K150870 | 000 |
| 00812636020662 | K150870 | 000 |