510(k) Report

Devices descending from K093286

14 later devices reach Powercross .018 Otw Pta Dilation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160004Crosstella OTWKANEKA Corporation20162—
+1K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+1K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+1K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+1K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+2K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+2K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+2K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+2K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+2K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+2K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+3K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+3K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+3K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501