ATLAAS (Atraumatic Left Atrial Appendage System) (AD)— 510(k) K252917
Substantially EquivalentGenesee Biomedical, Inc.
FDA 510(k) clearance K252917 for ATLAAS (Atraumatic Left Atrial Appendage System) (AD), Substantially Equivalent on 2026-05-22. Applicant: Genesee Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Genesee Biomedical, Inc.
- Product code
- Code PZX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denver, CO, US
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More clearances from Genesee Biomedical, Inc.
view allAdverse events under product code PZX
product code PZX- Death
- 6
- Total
- 6
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.