510(k) Report

Devices descending from K964435

17 later devices reach Primary IV Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…Victus, Inc.20100—
+1K082836Icu Medical Universal Single-Use SpikesIcu Medical, Inc.20090—
+1K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc.200812Class I
+1K080007Graduated Adapter with ClaveIcu Medical, Inc.20080—
+1K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc.20031—
+2K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc.201809
+2K131549Chemolock, Chemolock PortIcu Medical, Inc.201310Class I
+3K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+4K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+4K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+4K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+4K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+5K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd.20250—
+5K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd.20250—
+5K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd.20240—
+5K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+5K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—