ClearanceBrief
510(k) K191413 ยท PZX Left Atrial Appendage Clip, Implantable

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip

ApplicantAtriCure, Inc., Mason OH, US
DecisionSubstantially Equivalent, Aug 21, 2019
ReceivedMay 28, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K191413

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.