Artivion, Inc.
Kennesaw, GA, US
Artivion, Inc. appears in FDA device records in Kennesaw, GA. FDA records list 13 510(k) clearances between and , 77 PMA records and one registered establishment. As of , FDA records show 101 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Artivion, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cardiogenesis Corporationenforcement report, recall
- Cryolife, Inc.510(k), PMA, enforcement report, recall
510(k) clearance history
FDA records hold 13 510(k) clearances for Artivion, Inc. between 2006 and 2025. The busiest year on record is 2010, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 3 |
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 2 |
| 2019 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | OHA | Substantially Equivalent | |
| K183635 | PhotoFix Decellularized Bovine Pericardium | PSQ | Substantially Equivalent | |
| K172085 | PhotoFix Decellularized Bovine Pericardium | PSQ | Substantially Equivalent | |
| K162506 | PhotoFix Decellularized Bovine Pericardium | DXZ | Substantially Equivalent | |
| K132105 | PERCLOT TOPICAL | QSY | Substantially Equivalent | |
| K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX | FTM | Substantially Equivalent | |
| K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX | FTM | Substantially Equivalent | |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | DXZ | Substantially Equivalent | |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | OHA | Substantially Equivalent | |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | DXZ | Substantially Equivalent | |
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | OHA | Substantially Equivalent | |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | OHA | Substantially Equivalent | |
| K061892 | PROPATCH SOFT TISSUE REPAIR MATRIX | FTM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1063481 | 3001451326 | Artivion, Inc. | 1655 Roberts Blvd NW, Kennesaw, GA 30144 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based
- MUQGlue, Surgical, Arteries
- OHAHeart Valve, More Than Minimally Manipulated Allograft
- LWQHeart-Valve, Mechanical
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- DTJHolder, Heart-Valve, Prosthesis
- QSKHybrid Stent Graft, Thoracic Aortic Lesion Treatment
- MDMInstrument, Manual, Surgical, General Use
- DWSInstruments, Surgical, Cardiovascular
- PSQIntracardiac Patch Or Pledget, Biologically Derived
- FTMMesh, Surgical
- PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- LXNProbe, Test, Heart-Valve
- DTISizer, Heart-Valve, Prosthesis
- MNOSystem, Laser, Transmyocardial Revascularization
Recall records
Showing 25 of 101| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2532-2024 | (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology. | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. | Class II | Open, Classified | |
| Z-2531-2024 | CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology. | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. | Class II | Open, Classified | |
| Z-1545-2024 | CryoValve SG Cryopreserved Pulmonary Human Heart Valve | The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. | Class II | Open, Classified | |
| Z-0384-2022 | BioGlue Surgical Adhesive, Model BG3510-5-G | Product is not approved for use in the EU and should not have been distributed in the EU. | Class II | Terminated | |
| Z-0653-2021 | CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135 C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch. | On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall. | Class II | Terminated | |
| Z-0652-2021 | CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve. | On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall. | Class II | Terminated | |
| Z-1073-2019 | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position. | On-X Valve was mislabeled with the incorrect serial number. | Class II | Terminated | |
| Z-0121-2019 | CryoPatch SG Pulmonary Hemi-Artery, 1 graft | The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm. | Class II | Terminated | |
| Z-2556-2018 | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries). | The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes. | Class II | Terminated | |
| Z-2272-2018 | Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. | Class II | Terminated | |
| Z-2271-2018 | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. | Class II | Terminated | |
| Z-2623-2017 | BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J | The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. | Class II | Terminated | |
| Z-1219-2019 | CryoPatch SG Pulmonary Hemi-Artery Patch | The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae. | Class II | Terminated | |
| Z-2715-2017 | On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions | Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring. | Class II | Terminated | |
| Z-1674-2014 | BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries). | Serum albumin component monomer failed to meet internally established end of shelf-life specification. | Class II | Terminated | |
| Z-3108-2017 | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease. | Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. | Class II | Terminated | |
| Z-0809-2014 | Pulmonary Hemi-Artery SG Used in heart surgery | Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death. | Class II | Terminated | |
| Z-1993-2013 | Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization. | Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. | Class II | Terminated | |
| Z-1561-2011 | Pulmonary Hemi-Artery SG Used in heart surgery | Staphylococcus aureus (not methicillin resistant) identified in companion tissue. | Terminated | ||
| Z-1560-2011 | Pulmonary Valve & Conduit SG Used in heart surgery | Staphylococcus aureus (not methicillin resistant) identified in companion tissue. | Terminated | ||
| Z-1219-2011 | Pulmonary Valve & Conduit SG Used in heart surgery | A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus. | Terminated | ||
| Z-1524-2008 | CryoValve, Pulmonary Valve & Conduit | Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. | Terminated | ||
| Z-1523-2008 | CryoValve, Aortic Valve & Conduit | Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. | Terminated | ||
| Z-0842-2007 | Aortic Valve & Conduit | Donor tissue was released prior to information received regarding a pericardial effusion. | Terminated | ||
| Z-0841-2007 | CryoValve, Pulmonary Valve & Conduit | Donor tissue was released prior to information received regarding a pericardial effusion. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain