510(k) Report

Devices descending from K132430

19 later devices reach Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical, Ltd.20181—
+1K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+1K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+1K141150Pta Balloon Dilatation CatheterBoston Scientific Corp20148—
+1K141112Sterling Over-the Wire Pta Balloon Dilatation CatheterBoston Scientific20144—
+2K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+2K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc.20240—
+2K192399Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC20203—
+2K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+2K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+2K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+3K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+3K214038Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20222—
+3K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+3K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+3K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+4K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20241—
+4K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+5K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—