510(k) Report

Devices descending from K991977

2 later devices reach Tyshak, Model 102 and Z-Med, Model 302 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc.20041—
+2K153069Edwards Balloon CatheterEdwards Lifesciences20160—