510(k) Report

Devices descending from K011015

8 later devices reach Catheter Repair Kit with Replacement Connector, Model 5587000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc.20021—
+1K022570Medcomp Repair Kit, Model AspcrpkMedcomp200209
+1K022561Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.20024—
+2K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc.20060—
+2K030442Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.20033—
+3K063446Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.20062—
+4K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.20100—
+4K092797Acute and Chronic Catheter Repair KitKendall200901