The following data is part of a premarket notification filed by Biosphere Medical S.a. with the FDA for Quadrasphere Microspheres.
| Device ID | K151187 |
| 510k Number | K151187 |
| Device Name: | QuadraSphere Microspheres |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | BIOSPHERE MEDICAL S.A. PARC DES NATIONS - PARIS NORD 2, 383 RUE DE LA BELLE ETOILE Roissy-en-france, FR 95700 |
| Contact | Alix Fonlladosa |
| Correspondent | Lionel Ekedi Ngando BIOSPHERE MEDICAL S.A. PARC DES NATIONS - PARIS NORD 2, 383 RUE DE LA BELLE ETOILE Roissy-en-france, FR 95700 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-04 |
| Decision Date | 2015-07-27 |
| Summary: | summary |