AtriCure, Inc. · Class II · Cleared Nov 2, 2023
| K-number | K233407 |
| Device name | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) |
| Applicant | AtriCure, Inc. |
| Product code | PZX |
| Device class | Class II |
| Decision date | Nov 2, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 878.4300 |
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