510(k) Report

Devices descending from K080982

35 later devices reach Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110604VBB SystemSynthes201111
+1K111295.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation201193
+1K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+1K094019Glider Pta Balloon CatheterTrireme Medical, Inc.20104—
+1K093636Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model…Boston Scientific Corp200910—
+1K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp200921—
+2K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+2K150452ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC20151—
+2K141150Pta Balloon Dilatation CatheterBoston Scientific Corp20148—
+2K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+2K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME20143—
+2K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+2K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+2K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+2K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+2K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+2K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+2K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+2K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+3K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+3K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC202301
+3K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical20200—
+3K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+3K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+3K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc.,20150—
+3K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,20141—
+3K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+3K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+4K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+4K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+4K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+4K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+4K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—
+5K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+5K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—