510(k) Report

Devices descending from K052038

4 later devices reach Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0709512CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and…Boston Scientific20072—
+1K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific20063—
+2K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited20151—
+3K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20240—