FDA Registration
Active
🇺🇸 United States
Artivion, Inc.
Reg #: 1063481
·
FEI: 3001451326
·
Expires 2026
Products
13
Proprietary Names
19
Establishment Types
4
Classifications
13
Registration Details
- Registration Name
- Artivion, Inc.
- Registration Number
- 1063481
- FEI Number
- 3001451326
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1655 Roberts Blvd NW
- City
- Kennesaw
- State
- GA
- ZIP
- 30144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101866
- PMA Number
- P000037
Owner / Operator
- Firm Name
- Artivion, Inc.
- Operator Number
- 9003683
- Address
- 1655 ROBERTS BLVD., N.W., --
- City
- Kennesaw
- State
- GA
- Postal Code
- 30144
- Country
- US
- Correspondent
- Drew Green
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2016-05-13 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-08-18 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2016-08-17 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2013-12-11 |
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 2020-11-25 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 2016-05-13 |
| Hybrid Stent Graft, Thoracic Aortic Lesion Treatment | QSK | Class 3 | Unknown | No | 2024-12-12 |
| Probe, Test, Heart-Valve | LXN | Class 1 | Cardiovascular | No | 2016-05-13 |
| Agent, Absorbable Hemostatic, Non-Collagen Based | LMG | Class 3 | General, Plastic Surgery | No | 2023-05-22 |
| Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement | PAW | Class 2 | Cardiovascular | No | 2016-05-13 |
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | Class 2 | Cardiovascular | No | 2019-12-27 |
| Glue, Surgical, Arteries | MUQ | Class 3 | Unknown | No | 2007-11-02 |
| Heart Valve, More Than Minimally Manipulated Allograft | OHA | Class U | Unknown | No | 2026-01-13 |
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
PhotoFix Decellularized Bovine Pericardium
Chord-X Loops
BioGlue (R) Surgical Adhesive
CryoValve® SG Pulmonary Valve
CryoValve® SG Pulmonary Valve and Conduit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)