Artivion, Inc. · Chrysalis Intelligence

Total clearances

2025-10-02 → 2025-10-02

Last 12 months

Product codes

Most recent

2025-10-02

Trend

Clearance cadence by quarter

Portfolio

Code	Device name	Class	Specialty	Clearances	Most recent
OHA	Heart Valve, More Than Minimally Manipulated Allograft	Unclassified	Unknown	1	2025-10-02

Class III

Total PMA records

Originals + supplements

Distinct product codes

First decision

2026-06-26

Most recent

2026-06-26

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2026-06-26	P250055	AMDS Hybrid Prosthesis	Original	QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown

Safety

Class I (serious)

Risk of injury / death

Total recalls

Currently ongoing

Most recent

2024-05-28

Date	Severity	Status	Recall #	Product	Code	Reason
2024-05-28	Class II	Ongoing	Z-2532-2024	(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue …	—	Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
2024-05-28	Class II	Ongoing	Z-2531-2024	CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner…	—	Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
2024-03-06	Class II	Ongoing	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.

Filings

Date	K-number	Device	Code	Class	Specialty
2025-10-02	K252059	CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)	OHA	Unclassified	Unknown