510(k) Report

Devices descending from K163174

2 later devices reach Emerge PTCA Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223022SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.20230—
+1K220629Emerge Monorail PTCA Dilatation CatheterBoston Scientific20220—