ELUTIA INC.

FDA Device Registration & Listing · Gaithersburg, MD, US · Registration 3031160994

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031160994
FEI Number
3031160994
Entity Name
ELUTIA INC.
City/State/Country
Gaithersburg, MD, US
Establishment Address
20 Firstfield Rd, Gaithersburg, MD 20878, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Elutia Inc. (Owner Number: 10055257)
Owner / Operator Contact Address
20 Firstfield Road, Gaithersburg, MD 20878, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K051405
PMA Number
N/A

All Registered Proprietary Names

ECM for Vascular Repair VasCure for Vascular Repair ECM for Carotid Repair VasCure for Carotid Repair ECM for Pericardial Closure ProxiCor for Pericardial Closure

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2017-06-27
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2017-06-27
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2017-06-27

Official Correspondent

Erica Elchin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elutia Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3041851334 TAMABIO CO.,LTD. Musashino-shi Tokyo, JP
9680759 GLYCAR SA PTY., LTD. IRENE Gauteng, ZA
3006638824 ETHICON, INC. CIUDAD JUAREZ Chihuahua, MX
1835959 COOK BIOTECH, INC. West Lafayette, IN, US
1416980 BAXTER HEALTHCARE CORPORATION ROUND LAKE, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031160994. Last updated year: 2026. Please use registration number 3031160994 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.