Artivion, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Artivion, Inc.” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 93 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 93 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Artivion, Inc. took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHA | Heart Valve, More Than Minimally Manipulated Allograft | 1 | 1 |
| QSK | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment | 1 | 0 |
Review panels
- Cardiovascular (2)
Most recent Artivion, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | OHA | 2025-10-02 | 93 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250055 | PMA | AMDS Hybrid Prosthesis | 2026-06-26 |
Recalls
3 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2024-05-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Artivion, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07089576: Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA (Recruiting, started 2025-11-04)
- NCT05174767: PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection (Active not recruiting, started 2022-05-27)
- NCT03669042: Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery (Completed, started 2018-11-20)
- NCT02359994: Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System (Completed, started 2015-04)
SEC filings
ARTIVION, INC. (AORT): EDGAR filings, CIK 784199. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Artivion, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Artivion, Inc.” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Artivion, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Artivion, Inc. is 93 days.
Which FDA product codes appear under Artivion, Inc.?
The most frequent FDA product codes under this applicant name are OHA (Heart Valve, More Than Minimally Manipulated Allograft, 1); QSK (Hybrid Stent Graft, Thoracic Aortic Lesion Treatment, 1).
Next steps
- See all 1 Artivion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OHA, Artivion, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.