510(k) K193162 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
EPi-Sense Guided Coagulation System with VisiTrax
| Applicant | AtriCure, Inc., Mason OH, US |
| Decision | Substantially Equivalent, Dec 13, 2019 |
| Received | Nov 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193162
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.