510(k) Report

Devices descending from K111837

4 later devices reach Radial Artery Compression Tourniquet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142359Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd.20143—
+2K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc.20170—
+2K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc.201711
+3K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.20260—