510(k) K081465
K081465 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "AXIUM DETACHABLE COIL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 19, 2008. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Micro Therapeutics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2008
- Date Received
- May 27, 2008
- Clearance Type
- Traditional
- 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