510(k) Report

Devices descending from K131450

2 later devices reach Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x…Ostial Corporation20161—
+2K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.20260—