K212057 is an FDA 510(k) clearance for the Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Artventive Medical Group, Inc. (San Marcos, US). The FDA issued a Cleared decision on March 1, 2022, 243 days after receiving the submission on July 1, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K212057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2021 |
| Decision Date | March 01, 2022 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRD - Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |