The following data is part of a premarket notification filed by Biosphere Medical, S.a. with the FDA for Embosphere Microspheres.
| Device ID | K181300 |
| 510k Number | K181300 |
| Device Name: | Embosphere 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 | Rosene Amosse Biosphere Medical, S.A. Parc Des Nations – Paris Nord 2, 383 Rue De La Belle Etoile Roissy En France, FR 95700 |
| Product Code | KRD |
| Subsequent Product Code | HCG |
| Subsequent Product Code | NAJ |
| Subsequent Product Code | NOY |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-17 |
| Decision Date | 2018-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450403829 | K181300 | 000 |
| 10884450403058 | K181300 | 000 |
| 10884450403133 | K181300 | 000 |
| 10884450403157 | K181300 | 000 |
| 10884450403171 | K181300 | 000 |
| 10884450403201 | K181300 | 000 |
| 10884450403409 | K181300 | 000 |
| 10884450403423 | K181300 | 000 |
| 10884450403430 | K181300 | 000 |
| 10884450403447 | K181300 | 000 |
| 10884450403454 | K181300 | 000 |
| 10884450403461 | K181300 | 000 |
| 10884450403713 | K181300 | 000 |
| 10884450402945 | K181300 | 000 |