510(k) Report

Devices descending from K180824

6 later devices reach VaPro 2 Intermittent Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220667Sleeved ICHollister Incorporated20223—
+1K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated20181—
+2K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…Hollister Incorporated20242—
+2K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated20190—
+3K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated20260—
+3K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…Hollister Incorporated20250—