The following data is part of a premarket notification filed by Artventive Medical Group, Inc with the FDA for Endoluminal Occlusion System-eos.
| Device ID | K150402 |
| 510k Number | K150402 |
| Device Name: | Endoluminal Occlusion System-EOS |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | ARTVENTIVE MEDICAL GROUP, INC 2766 Gateway Road Carlsbad, CA 92009 |
| Contact | Roberta Hines |
| Correspondent | Roberta Hines Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, WA 98072 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B617PSG1751 | K150402 | 000 |
| B617PSG161 | K150402 | 000 |
| B617PG181 | K150402 | 000 |
| B617PG151 | K150402 | 000 |
| B617PG1111 | K150402 | 000 |