The following data is part of a premarket notification filed by Artio Medical, Inc. with the FDA for Solus Gold Embolization Device.
| Device ID | K213200 |
| 510k Number | K213200 |
| Device Name: | Solus Gold Embolization Device |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Artio Medical, Inc. 127 Independence Drive Menlo Park, CA 94025 |
| Contact | Erdie De Peralta |
| Correspondent | Erdie De Peralta Artio Medical, Inc. 127 Independence Drive Menlo Park, CA 94025 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850034171067 | K213200 | 000 |
| 00850034171050 | K213200 | 000 |
| 00850034171043 | K213200 | 000 |
| 00850034171036 | K213200 | 000 |
| 00850034171029 | K213200 | 000 |
| 00850034171012 | K213200 | 000 |
| 00850034171005 | K213200 | 000 |