510(k) Report

Devices descending from K011965

10 later devices reach Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102527Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip…Boston Scientific Corporation201031
+1K090270Backstop Catheter, Model 60-0000-3100Pluromed, Inc.20094—
+1K013360Dfiner Urological CatheterNeoseed Technology,Llc20020—
+2K180530Imager II Urology Torque CatheterBoston Scientific Corporation20180—
+2K171600Renal Access Cobra Catheter, Kumpe Access CatheterCook Incorporated20181—
+2K103349Backstop CatheterPluromed, Inc.20113—
+3K181144Angled Tip Ureteral CatheterCook Incorporated20180—
+3K110491Backstop CatheterPluromed, Inc.20112—
+4K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.20181—
+5K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.20210—