510(k) Report

Devices descending from K993564

94 later devices reach Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090253Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior…Possis Medical, Inc.200932—
+1K073441Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc.200835—
+1K061951Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc.200666—
+1K040013Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary KitPossis Medical, Inc.200470—
+1K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH200119—
+2K091593Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc.200931—
+2K082382Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc.200834—
+2K072404Erbe Erbejet 2 SystemErbe USA, Inc.200714—
+2K072269Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc.200733—
+2K071336Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc.200733—
+2K071514Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc.200763—
+2K071342Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041…Possis Medical, Inc.200734—
+2K052256Angiojet Xpeedior 120 CatheterPossis Medical, Inc.200568—
+2K050794Angiojet DVX Rheolytic Thrombectomy CatheterPossis Medical, Inc.2005341
+2K021813Hydrocision General Surgery Fluidjet SystemHydrocision, Inc.20030—
+2K022613Helix Hydro-JetErbe USA, Inc.200217—
+3K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH20231—
+3K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.201512—
+3K133629Angiojet Ultra Avx Thrombectomy SetPossis Medical, Inc.201401
+3K130381Angiojet Ultra Power Pulse KitMedrad, Inc.20130—
+3K113428Angiojet Ultra DVX Thrombectomy SetMedrad, Inc.20110—
+3K111182Angiojet Solent Omni Thrombectomy SetMedrad, Inc.2011281
+3K101406Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis201030—
+3K083608Erbe Hybrid KnifeErbe USA, Inc.200913—
+3K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc.200928—
+3K033590Erbe Helix Hydro-JetErbe USA, Inc.200416—
+4K243120HybridAPC probeErbe Elektromedizin GmbH20251—
+4K232033HYBRIDknife® flexErbe Elektromedizin GmbH20230—
+4K200404ORISE ProKnifeBoston Scientific Corporation20200—
+4K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.201772
+4K151313ZelanteDVT Thrombectomy SetBoston Scientific Corporation201526—
+4K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc.201201
+4K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.201022—
+4K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…Pathway Medical Technologies, Inc.200925—
+4K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.200926—
+4K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc.200927—
+4K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc.200714—
+5K253915MOVIVA® Hybrid Ablation ProbeErbe Elektromedizin GmbH20250—
+5K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…Olympus Medical Systems Corporation20250—
+5K212999Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd.20220—
+5K202218ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceBoston Scientific Corporation20203—
+5K193462ClotTriever Thrombectomy SystemInari Medical202021—
+5K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd.20201—
+5K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…Hangzhou AGS MedTech Co., Ltd.20200—
+5K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp.201913
+5K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc.20135—
+5K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.201214—
+5K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…Pathway Medical Technologies, Inc.201110—
+5K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…Pathway Medical Technologies, Inc.201020—
+5K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc.201019—
+5K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…Pathway Medical Technologies, Inc.201023—
+5K093456Jetstream G3 SystemPathway Medical Technologies, Inc.200924—
+6K243549JETi Hydrodynamic Thrombectomy SystemAbbott Medical20250—
+6K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+6K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd.20210—
+6K210190ClotTriever Thrombectomy SystemIrani Medical, Inc.202120—
+6K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+6K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+6K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc.20146—
+6K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc.20126—
+6K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+6K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc.201115—
+7K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+7K210689ClotTriever Thrombectomy SystemInari Medical, Inc.202119—
+7K172315Straub Endovascular SystemStraub Medical AG20182Class I
+7K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+7K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc.20152—
+7K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc.20145—
+8K220887Mini-ClotTriever Thrombectomy SystemInari Medical20222—
+8K212632ClotTriever Thrombectomy SystemInari Medical, Inc.202115—
+8K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+8K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+8K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.20181—
+8K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…Volcano Atheromed, Inc.20172—
+8K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy…Volcano Atheromed, Inc.20143—
+9K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+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—
+9K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+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—