ClearanceBrief
510(k) K183065 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Coolrail Linear Pen

ApplicantAtriCure, Inc., Mason OH, US
DecisionSubstantially Equivalent, Dec 4, 2018
ReceivedNov 5, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K183065

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.