510(k) Report

Devices descending from K113103

5 later devices reach Splitwire Percutaneous Transluminal Angioplasty Scoring Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+1K152789Flex Scoring CatheterVenturemed Group20161—
+2K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+2K202187FLEX Vessel Prep SystemVenturemed Group, Inc.20200—
+3K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—