510(k) Report

Devices descending from K090822

13 later devices reach Advance 14RX Rapid Exchange Pta Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170193Advance 14LP Low Profile PTA Balloon Dilatation CatheterCook Incorporated20170—
+1K122940Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3Cook, Inc.20132—
+1K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+2K152934MMS PTA Balloon CatheterMicro Medical Solutions, Inc.20160—
+2K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+2K140593Advance Salivary Balloon Catheter with Wire GuideCook, Inc.20140—
+2K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+3K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+3K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+4K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+5K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+5K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+6K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—