510(k) Report

Devices descending from K190604

5 later devices reach PIVO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K22025820G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)Avia Vascular20220—
+1K193569Pivo (TM)Velano Vascular202031
+2K230865PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc.20232—
+3K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc.20250—
+3K241586PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc.20250—