510(k) Report

Devices descending from K003320

3 later devices reach Pta-OS Sizing Balloon, Model 360 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053440Amplatzer Sizing Balloon IIAga Medical Corp.200502
+1K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc.20041—
+2K153069Edwards Balloon CatheterEdwards Lifesciences20160—