Data / Medical devices / United States / Elutia Inc.
Elutia Inc.: FDA-registered device maker in Gaithersburg, MD, United States, 5 510(k) clearances
Elutia Inc. is registered with the FDA (registration 3031160994) in Gaithersburg, MD, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated February 4, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3031160994
- Address
- 20 Firstfield Rd, Gaithersburg, MD, United States, 20878
- Owner or operator
- Elutia Inc. (10055257)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 27, 2017
- Registered through
- 2027
- Brand names listed
- ECM for Cardiac Tissue Repair, ECM for Carotid Repair, ECM for Pericardial Closure, ECM for Vascular Repair, ProxiCor for Cardiac Tissue Repair, ProxiCor for Pericardial Closure, Tyke, VasCure for Carotid Repair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 4, 2016 | K152127 | CorMatrix Tyke | DXZ | Substantially Equivalent | Cormatrix Cardiovascular, Inc. | accessdata.fda.gov |
| July 15, 2014 | K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | DXZ | Substantially Equivalent | Cormatrix Cardiovascular, Inc. | accessdata.fda.gov |
| July 26, 2011 | K111187 | PATCH, PLEDGET AND INTRACARDIAC | DXZ | Substantially Equivalent | Cormatrix Cardiovascular, Inc. | accessdata.fda.gov |
| February 16, 2007 | K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR | DXZ | Substantially Equivalent | Cormatrix Cardiovascular, Inc. | accessdata.fda.gov |
| August 31, 2005 | K051405 | REGENSIS PERICARDIAL PATCH | DXZ | Substantially Equivalent | Cormatrix Cardiovascular, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 4, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.