510(k) Report

Devices descending from K070951

2 later devices reach 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited20151—
+2K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20240—