510(k) Report

Devices descending from K111284

5 later devices reach Flash-C Ptca Balloon Dilation Catheter - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131450Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X 8MM X…Ostial Corporation20132—
+1K113775Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM-…Ostial Corporation20124—
+2K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x…Ostial Corporation20161—
+2K122178Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash-C Ptca Balloon…Ostial Corporation20123—
+3K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.20260—