510(k) K151187
K151187 is an FDA 510(k) premarket notification submitted by Biosphere Medical, S.A. for the device "QuadraSphere Microspheres". The FDA issued a decision of Substantially Equivalent on July 27, 2015. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Biosphere Medical, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2015
- Date Received
- May 4, 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