Chrysalis Intelligence · Sponsors · Artivion, Inc.

Artivion, Inc.

Kennesaw, GA, US · 1 510(k) clearances · 1 PMAs · 3 recalls

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Total clearances
1
2025-10-02 → 2025-10-02
Last 12 months
1
Product codes
1
Most recent
2025-10-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OHA — — — 1 2025-10-02
Class III

PMA approvals (1)

Total PMA records
1
Originals + supplements
Distinct product codes
1
First decision
2026-06-26
Most recent
2026-06-26
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-26 P250055 AMDS Hybrid Prosthesis Original QSK Hybrid Stent Graft, Thoracic Aortic Lesion Treatment Unknown
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2024-05-28
DateSeverityStatusRecall # ProductCodeReason
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

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2025-10-02 K252059 CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) OHA — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence