510(k) Report

Devices descending from K030209

5 later devices reach Mahurkar Oplus Catheter, Model 13.5 FR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+1K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+1K063355D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp.20071—
+2K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+2K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd.20110—