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.
Summary
Genesee Biomedical's ATLAAS (Atraumatic Left Atrial Appendage System) (AD) is filed under PZX, implantable left atrial appendage clips.
Class II, 21 CFR 878.4300. The Cardiovascular review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Genesee filed from Denver, Colorado. The decision came 252 calendar days after receipt (September 12, 2025 to May 22, 2026).
Clearance details
- Applicant
- Genesee Biomedical, Inc.
- Product code
- Product 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.