510(k) Report

Devices descending from K083354

2 later devices reach Floraseal, Model FS350D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC20171—
+2K223669SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC20230—