510(k) Report

Devices descending from K243820

1 later device reach Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—