510(k) Report

Devices descending from K081229

13 later devices reach Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142946TIVAVelano Vascular, Inc.20158—
+1K122687Blood Culture HolderGreiner Bio-One North America, Inc.20133—
+2K242320BD Vacutainer® One Use HolderBecton, Dickinson and Company20240—
+2K193074Bevel Up HolderNsp Tech Pte, Ltd.20201—
+2K152924TIVA¿Velano Vascular20167—
+3K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd.20230—
+3K163508PIVOVelano Vascular20176—
+4K190604PIVOVelano Vascular20195—
+5K22025820G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)Avia Vascular20220—
+5K193569Pivo (TM)Velano Vascular202031
+6K230865PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc.20232—
+7K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc.20250—
+7K241586PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc.20250—