AtriClip LAA Exclusion System— 510(k) K210293
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K210293 for AtriClip LAA Exclusion System, Substantially Equivalent on 2021-03-03. Applicant: AtriCure, Inc.. Device class: 2.
Clearance details
- Applicant
- AtriCure, 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
- Special
- Location
- Mason, OH, US
Recent devices under product code PZX
view all- K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (4 models)
- K252917 — ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
- K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM)
- K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 more
More clearances from AtriCure, 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.