AtriClip PRO-Mini LAA Exclusion System (PROM)— 510(k) K243860
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K243860 for AtriClip PRO-Mini LAA Exclusion System (PROM), Substantially Equivalent on 2025-01-15. Applicant: AtriCure, Inc.. Device class: 2.
Clearance details
- Applicant
- AtriCure, 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
- Special
- Location
- Mason, OH, US
Recent devices under product code PZX
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- K232295 — LAA Exclusion System
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.