Anteris Technologies Corporation

FDA Device Registration & Listing · Eagan, MN, US · Registration 3012664855

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
3012664855
FEI Number
3012664855
Entity Name
Anteris Technologies Corporation
City/State/Country
Eagan, MN, US
Establishment Address
860 Blue Gentian Rd Ste 340, Eagan, MN 55121, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Anteris Technology Corporation (Owner Number: 10046278)
Owner / Operator Contact Address
860 Blue Gentian Road, Suite 340, Eagan, MN 55121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200566
PMA Number
N/A

All Registered Proprietary Names

ADAPT Tissue

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2020-06-09

Official Correspondent

Renee Cveykus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Anteris Technology Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010805634 Anteris Aus Operations Pty Ltd Malaga Western Australia, AU

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1047843 ISOMEDIX OPERATIONS INC. SPARTANBURG, SC, US
3010805634 Anteris Aus Operations Pty Ltd Malaga Western Australia, AU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012664855. Last updated year: 2026. Please use registration number 3012664855 when referencing this establishment in official correspondence.
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