510(k) Report

Devices descending from K970159

5 later devices reach Flex-Neck PD Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071167Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560Medigroup, Inc.20072—
+1K070730Flex-Neck Arc CatheterMedigroup, Inc.20070—
+1K031351Flex-Neck PD Catheter, InfantMedigroup, Inc.200313
+2K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…Covidien, LLC20180—
+2K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—