510(k) Report

Devices descending from K141150

8 later devices reach Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+1K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+1K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+2K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+2K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+2K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+2K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+3K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—