K183578 is an FDA 510(k) clearance for the Torpedo Gelatin Foam. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Biosphere Medical, S.A. (Roissy-En-France, FR). The FDA issued a Cleared decision on June 18, 2019, 179 days after receiving the submission on December 21, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K183578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2018 |
| Decision Date | June 18, 2019 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRD - Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |