510(k) K163408 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Isolator Multifunctional Linear Pen
| Applicant | AtriCure, Inc., Mason OH, US |
| Decision | Substantially Equivalent, Jan 3, 2017 |
| Received | Dec 5, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163408
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.