510(k) Report

Devices descending from K024007

2 later devices reach Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30J through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070451Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd.20071—
+2K193158ACENT™ Central Venous CatheterGlobal Medikit Limited20200—