510(k) Report

Devices descending from K010880

2 later devices reach Numed High Pressure Pta Catheters through their predicates, nearest generation first.

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