ELUTIA INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3031160994 | 3031160994 | ELUTIA INC. | 1 | N | 2026-01-01 | 20 Firstfield Rd Gaithersburg MD US 20878 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 343951 | 1974842128 | K152127 | CorMatrix Tyke | DXZ | 2016-02-04 |
| 343951 | 1838029059 | K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | DXZ | 2014-07-15 |
| 343951 | 1897604321 | K111187 | PATCH, PLEDGET AND INTRACARDIAC | DXZ | 2011-07-26 |
| 343951 | 1685799382 | K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR | DXZ | 2007-02-16 |
| 343951 | 1975287080 | K051405 | REGENSIS PERICARDIAL PATCH | DXZ | 2005-08-31 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DXZ | 5 | 2016-02-04 |