510(k) Report

Devices descending from K181323

4 later devices reach Atlas Gold PTA Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20260—
+1K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+2K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+3K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—