510(k) K133924
K133924 is an FDA 510(k) premarket notification submitted by Artventive Medical Group, Inc. for the device "ENDOLUMINAL OCCLUSION SYSTEM (EOS)". The FDA issued a decision of Substantially Equivalent on Dec 3, 2014. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Artventive Medical Group, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 3, 2014
- Date Received
- Dec 23, 2013
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vascular, For Promoting Embolization
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- CV
- Submission Type
- 510(k)