510(k) K091626 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
| Applicant | Cryolife, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Aug 7, 2009 |
| Received | Jun 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2024 | Artivion, Inc (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 Pulmona Open, Classified |
DXZ | None listed |
| Sep 6, 2018 | CryoLife, Inc. CryoPatch SG Pulmonary Hemi-Artery, 1 graft Terminated |
DXZ | None listed |
| Nov 21, 2016 | CryoLife, Inc. CryoPatch SG Pulmonary Hemi-Artery Patch Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.