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 |