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 | K133924 |
| 510k Number | K133924 |
| Device Name: | ENDOLUMINAL OCCLUSION SYSTEM (EOS) |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | ARTVENTIVE MEDICAL GROUP, INC 24125 85TH AVENUE SE Woodinville, WA 98072 |
| Contact | Roberta Hines |
| Correspondent | Roberta Hines ARTVENTIVE MEDICAL GROUP, INC 24125 85TH AVENUE SE Woodinville, WA 98072 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-12-03 |
| Summary: | summary |