510(k) Report

Devices descending from K052256

68 later devices reach Angiojet Xpeedior 120 Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130381Angiojet Ultra Power Pulse KitMedrad, Inc.20130—
+1K072269Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc.200733—
+1K071336Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc.200733—
+1K071342Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041…Possis Medical, Inc.200734—
+1K071514Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc.200763—
+1K061951Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc.200666—
+2K091593Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc.200931—
+2K090253Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior…Possis Medical, Inc.200932—
+2K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc.200928—
+3K113428Angiojet Ultra DVX Thrombectomy SetMedrad, Inc.20110—
+3K111182Angiojet Solent Omni Thrombectomy SetMedrad, Inc.2011281
+3K101406Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis201030—
+3K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.201022—
+3K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…Pathway Medical Technologies, Inc.200925—
+3K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.200926—
+3K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc.200927—
+4K151313ZelanteDVT Thrombectomy SetBoston Scientific Corporation201526—
+4K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc.20135—
+4K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc.201201
+4K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.201214—
+4K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…Pathway Medical Technologies, Inc.201110—
+4K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…Pathway Medical Technologies, Inc.201020—
+4K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc.201019—
+4K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…Pathway Medical Technologies, Inc.201023—
+4K093456Jetstream G3 SystemPathway Medical Technologies, Inc.200924—
+5K202218ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceBoston Scientific Corporation20203—
+5K193462ClotTriever Thrombectomy SystemInari Medical202021—
+5K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+5K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+5K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc.20146—
+5K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc.20126—
+5K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+5K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc.201115—
+6K243549JETi Hydrodynamic Thrombectomy SystemAbbott Medical20250—
+6K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+6K210190ClotTriever Thrombectomy SystemIrani Medical, Inc.202120—
+6K172315Straub Endovascular SystemStraub Medical AG20182Class I
+6K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+6K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc.20152—
+6K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc.20145—
+7K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+7K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+7K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+7K210689ClotTriever Thrombectomy SystemInari Medical, Inc.202119—
+7K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.20181—
+7K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…Volcano Atheromed, Inc.20172—
+7K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy…Volcano Atheromed, Inc.20143—
+8K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+8K220887Mini-ClotTriever Thrombectomy SystemInari Medical20222—
+8K212632ClotTriever Thrombectomy SystemInari Medical, Inc.202115—
+8K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+9K223210ClotTriever XL CatheterInari Medical, Inc.20231Class I
+9K230494ClotTriever BOLD CatheterInari Medical, Inc.20230—
+9K223613InThrill Thrombectomy SystemInari Medical, Inc.20231—
+9K223609RevCore™ Thrombectomy Catheter.Inari Medical, Inc.20232—
+9K223891Cobra Catheter SystemEndovascular Engineering20232—
+9K221531ClotTriever Thrombectomy SystemInari Medical, Inc.20230—
+9K223000Artix BGInari Medical20233—
+9K220415Protrieve SheathInari Medical, Inc.20220—
+10K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+10K251185Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)Intervene20250—
+10K250421InThrill™ Thrombectomy SystemInari Medical, Inc.20250—
+10K242557ClotTriever XL Catheter (41-102)Inari Medical, Inc.20240—
+10K234034VenaCore Thrombectomy Catheter (46-101)Inari Medical, Inc.20240—
+10K230912Artix BGInari Medical20232—
+11K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+11K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc.202411
+12K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.20260—