The following data is part of a premarket notification filed by Biosphere Medical, S.a. with the FDA for Torpedo Gelatin Foam.
| Device ID | K183578 |
| 510k Number | K183578 |
| Device Name: | Torpedo Gelatin Foam |
| 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 | 2018-12-21 |
| Decision Date | 2019-06-18 |