ClearanceBrief
510(k) K233407 ยท PZX Left Atrial Appendage Clip, Implantable

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 (PRO

ApplicantAtriCure, Inc., Mason OH, US
DecisionSubstantially Equivalent, Nov 2, 2023
ReceivedOct 5, 2023
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K233407

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.