CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH— 510(k) K091626
Substantially EquivalentCryolife, Inc.
FDA 510(k) clearance K091626 for CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH, Substantially Equivalent on 2009-08-07. 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
- Traditional
- 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 K091626
K-number listed on FDA's recall record- Z-2532-2024 — (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 Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
- Z-0121-2019 — CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Z-1219-2019 — CryoPatch SG Pulmonary Hemi-Artery Patch
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091626.
Data sourced from openFDA. This site is unofficial and independent of the FDA.