ClearanceBrief
510(k) K200060 ยท QLZ Septostomy Catheter, Reprocessed

Reprocessed NRG Transseptal Needle

ApplicantInnovative Health, LLC, Scottsdale AZ, US
DecisionSubstantially Equivalent, Jul 30, 2020
ReceivedJan 13, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K200060

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.