510(k) Report

Devices descending from K041993

5 later devices reach 2 CM Peripheral Cutting Baloon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited20151—
+1K0709512CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and…Boston Scientific20072—
+1K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation200542
+2K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20240—
+2K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific20063—