510(k) Report

Devices descending from K974389

1 later device reach Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLC20250—