510(k) Report

Devices descending from K012044

7 later devices reach BI-Phasic Infiltrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040149Psi-Tec Peristaltic Infiltration PumpByron Medical20046—
+2K101413Euromi Eva SP6Euromi S.A20100—
+2K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102—
+2K071588Dispenser DP 20Nouvag AG20070—
+2K050324Infpump Infiltration PumpCarolina Medical, Inc.20050—
+3K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC20121—
+4K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC20130—