Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063481

FEI Number

3001451326

Entity Name

Artivion, Inc.

City/State/Country

Kennesaw, GA, US

Establishment Address

1655 Roberts Blvd NW, Kennesaw, GA 30144, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Artivion, Inc. (Owner Number: 9003683)

Owner / Operator Contact Address

1655 ROBERTS BLVD., N.W., --, Kennesaw, GA 30144, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121173

PMA Number

N/A

All Registered Proprietary Names

On-X Prosthetic Aortic Heart Valves with Anatomic Sewing Ring On-X AAP Ascending Aortic Prosthesis On-X Prosthetic Heart Valves On-X Conform-X Prosthetic Heart Valves Chordal Sizer On-X Instruments: handle and rotators CryoPatch SG Pulmonary Human Cardiac Patch On-X Heart Valve Holder On-X Heart Valve Instrumentation AMDS Hybrid Prosthesis On-X Heart Valve Instruments PhotoFix PerClot Polysaccharide Hemostatic System Chord-X ePTFE Suture

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2016-05-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-08-18
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2016-08-17
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2013-12-11
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3935	2020-11-25
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	2016-05-13
QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown	Class 3	N/A	2024-12-12
LXN	Probe, Test, Heart-Valve	Cardiovascular	Class 1	870.4500	2016-05-13
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2019-12-27
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2023-05-22
PAW	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	Cardiovascular	Class 2	870.3470	2016-05-13

Official Correspondent

Drew Green

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Artivion, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K813276	Shiley, Inc.	IONESCU-SHILEY VALVE HOLDER & HANDLE	1981-12-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-04	Cryolife Inc	3	CryoValve, Pulmonary Valve & Conduit SG
Z-0026-05	Cryolife Inc	3	CryoValve, Pulmonary Valve & Conduit
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063481. Last updated year: 2026. Please use registration number 1063481 when referencing this establishment in official correspondence.