CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH— 510(k) K101866
Substantially EquivalentCryolife, Inc.
FDA 510(k) clearance K101866 for CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH, Substantially Equivalent on 2010-07-23. Applicant: Cryolife, Inc.. Device class: 2.
Clearance details
- Applicant
- Cryolife, Inc.
- Product code
- Code DXZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3470
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kennesaw, GA, US
Recent devices under product code DXZ
view allMore clearances from Cryolife, Inc.
view allAdverse events under product code DXZ
product code DXZ- Death
- 19
- Injury
- 265
- Total
- 284
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101866
K-number listed on FDA's recall record- Z-0653-2021 — 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 packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135¿ C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.
- Z-2272-2018 — Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
- Z-0809-2014 — Pulmonary Hemi-Artery SG Used in heart surgery
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101866.
Data sourced from openFDA. This site is unofficial and independent of the FDA.