510(k) Report

Devices descending from K041791

2 later devices reach 5.2F Dual Lumen Extended Length Catheter (Delc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc.20231—
+2K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…Nuwellis, Inc.20250—