510(k) Report

Devices descending from K022061

9 later devices reach Cvsi Peripheral Balloon Catheter; Cvsi Inflater through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051254Peripheral Cutting BalloonBoston Scientific Ivt20055—
+1K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt20045—
+1K040155Peripheral Cutting BalloonBoston Scientific Corp20046—
+1K023463Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation UnitCryo Vascular Systems, Inc.20030—
+2K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited20151—
+2K0709512CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and…Boston Scientific20072—
+2K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation200542
+3K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20240—
+3K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific20063—