510(k) Report

Devices descending from K040301

1 later device reach Gamcath High Flow Catheter, Ref: GDHK 13XX a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100451Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…Gambro Renal Products, Inc.20100—