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Artivion, Inc.

United States·US-MF-000015763

Last updated September 17, 2026

Information

Country: United States
Address: 1655, Roberts Boulevard NW, Kennesaw, United States
Website: www.artivion.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 770-419-3355
PRRC Contact: Drew Green
EUDAMED SRN: US-MF-000015763
FDA FEI Number: 3001451326
DUNS Number: 119253177

Catalogue (52)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
PhotoFix Decellularized Bovine Pericardium	PFP 6x8	FDA UDI	Class II	Active
PhotoFix Decellularized Bovine Pericardium	PFP4X4	FDA UDI	Class II	Active
BioGlue Surgical Adhesive	BGAT-SY	FDA UDI	Class III	Unknown
PhotoFix Decellularized Bovine Pericardium	PFP0.8X8	FDA UDI	Class II	Active
BioGlue Surgical Adhesive	BGAT-27-SY	FDA UDI	Class III	Unknown
CardioGenesis	NS2000	FDA UDI	Class III	Active
BioGlue Surgical Adhesive	BGST-12	FDA UDI	Class III	Active
BioGlue Surgical Adhesive	BGAT-10-SY	FDA UDI	Class III	Unknown
BioGlue Surgical Adhesive	BGAT-10-SY	FDA UDI	Class III	Active
Bioglue Surgical Adhesive	BGDTE-27	FDA UDI	Class III	Unknown
PhotoFix Decellularized Bovine Pericardium	PFP1X10	FDA UDI	Class II	Active
BioGlue Surgical Adhesive	BGST-16	FDA UDI	Class III	Unknown
BioGlue Surgical Adhesive	BGST-12	FDA UDI	Class III	Unknown
AMDS Hybrid Prosthesis ("AMDS")	K039421	FDA UDI	Class III	Active
CardioGenesis	HP-SG3	FDA UDI	Class III	Unknown
PhotoFix Decellularized Bovine Pericardium	PFP8X14	FDA UDI	Class II	Active
HeRO® Graft Arterial Graft Component	HERO 1002	FDA UDI	Class II	Unknown
AMDS Hybrid Prosthesis ("AMDS")	K039423	FDA UDI	Class III	Active
BioGlue Surgical Adhesive	BG3502-5-US	FDA UDI	Class III	Unknown
PhotoFix Decellularized Bovine Pericardium	PFP2X9	FDA UDI	Class II	Active
AMDS Hybrid Prosthesis ("AMDS")	K039420	FDA UDI	Class III	Active
BioGlue Surgical Adhesive	BGAT-SY	FDA UDI	Class III	Active
PhotoFix Decellularized Bovine Pericardium	PFP6X8	FDA UDI	Class II	Active
HeRO® Graft Accessory Component Kit	HERO 1003	FDA UDI	Class II	Unknown
BioGlue Surgical Adhesive	BG3515-5-US	FDA UDI	Class III	Unknown
CryoPatch® SG Pulmonary Human Cardiac Trunk Patch	SGP010	FDA UDI	Class II	Active
BioGlue Surgical Adhesive	BGST-16	FDA UDI	Class III	Active
PhotoFix Decellularized Bovine Pericardium	PFP1X6	FDA UDI	Class II	Active
CryoPatch® SG Pulmonary Human Cardiac Branch Patch	SGP020	FDA UDI	Class II	Active
BioGlue Surgical Adhesive	BGDTE-27	FDA UDI	Class III	Active
CardioGenesis	HP-PRL5	FDA UDI	Class III	Unknown
BioGlue Surgical Adhesive	BG3502-5-US	FDA UDI	Class III	Active
BioGlue Surgical Adhesive	BG3510-5-US	FDA UDI	Class III	Unknown
CryoValve® SG Pulmonary Human Heart Valve	SGPV00	FDA UDI	U	Active
PhotoFix Decellularized Bovine Pericardium	PFP1X14	FDA UDI	Class II	Active
BioGlue Surgical Adhesive	BG3510-5-US	FDA UDI	Class III	Active
BioGlue Surgical Adhesive	BG3515-5-US	FDA UDI	Class III	Active
AMDS Hybrid Prosthesis ("AMDS")	K039422	FDA UDI	Class III	Active
CryoValve® SG Pulmonary Human Heart Valve	SGPV10	FDA UDI	U	Active
HeRO® Graft Adapter	HERO 1004	FDA UDI	Class II	Unknown
AMDS Hybrid Prosthesis ("AMDS")	K038895	FDA UDI	Class III	Active
HeRO® Graft Venous Outflow Component	HERO 1001	FDA UDI	Class II	Unknown
AMDS Hybrid Prosthesis ("AMDS")	K038896	FDA UDI	Class III	Active
CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch	SGPH00	FDA UDI	Class II	Active
BioGlue Surgical Adhesive	BGAT-27-SY	FDA UDI	Class III	Active
BioGlue Surgical Adhesive	BGDTE-10	FDA UDI	Class III	Active
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)	K252059	FDA 510(k)	U	Active
PhotoFix Decellularized Bovine Pericardium	PFP8X14-G	EUDAMED	Class III	Active
PhotoFix Decellularized Bovine Pericardium	PFP1X6-G	EUDAMED	Class III	Active
PhotoFix Decellularized Bovine Pericardium	PFP6X8-G	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

JOTEC GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 28, 2024	Z-2531-2024	—	open, classified	Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
May 28, 2024	Z-2532-2024	—	open, classified	Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Mar 6, 2024	Z-1545-2024	—	open, classified	The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.