The following data is part of a premarket notification filed by Biosphere Medical, S.a. with the FDA for Embocube Embolization Gelatin.
| Device ID | K181021 |
| 510k Number | K181021 |
| Device Name: | EmboCube Embolization Gelatin |
| 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 | Alix Fonlladosa 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 | 2018-04-17 |
| Decision Date | 2018-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450306229 | K181021 | 000 |