AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip— 510(k) K191413
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K191413 for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip, Substantially Equivalent on 2019-08-21. 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
- Traditional
- Location
- Mason, OH, US
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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.