K151187 is an FDA 510(k) clearance for the QuadraSphere Microspheres. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Biosphere Medical, S.A. (Roissy-En-France, FR). The FDA issued a Cleared decision on July 27, 2015, 84 days after receiving the submission on May 4, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K151187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2015 |
| Decision Date | July 27, 2015 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | KRD - Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |