510(k) K162704
K162704 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular for the device "Axium Prime Detachable Coil System". The FDA issued a decision of Substantially Equivalent on Jan 3, 2017. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 3, 2017
- Date Received
- Sep 28, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Neurovascular Embolization
- Device Class
- Class II
- Regulation Number
- 882.5950
- Review Panel
- NE
- Submission Type
- 510(k)