510(k) K101866 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
| Applicant | Cryolife, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Jul 23, 2010 |
| Received | Jul 2, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Artivion, Inc CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010 Open, Classified |
DXZ | None listed |
| Nov 10, 2020 | CryoLife, Inc. 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 packagin Terminated |
DXZ | None listed |
| May 14, 2018 | CryoLife, Inc. Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 Terminated |
DXZ | None listed |
| Jan 23, 2014 | CryoLife, Inc. Pulmonary Hemi-Artery SG
Used in heart surgery Terminated |
DXZ | None listed |
| Mar 4, 2011 | CryoLife, Inc. Pulmonary Hemi-Artery SG
Used in heart surgery Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.