510(k) Report

Devices descending from K230411

1 later device reach Dragonfly OpStar™ Imaging Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242098Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…Shenzhen Vivolight Medical Device & Technology Co., Ltd.20250—