510(k) K152157
K152157 is an FDA 510(k) premarket notification submitted by Biocompatibles UK , Ltd. for the device "LC Bead LUMI". The FDA issued a decision of Substantially Equivalent on December 11, 2015. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Biocompatibles UK , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2015
- Date Received
- August 3, 2015
- 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