510(k) Report

Devices descending from K022380

73 later devices reach Livesire Electrophysiology Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160242Reprocessed Livewire Steerable Diagnostic EP CatheterInnovative Health, LLC20161—
+1K160390Map-it Diagnostic Mapping CathetersAccess Point Technologies Ep, Inc.20161—
+1K151617Livewire Electrophysiology CatheterSurgical Instrument Service and Savings Inc.(Dba Medline Ren20160—
+1K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…St Jude Medical201511—
+1K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter…St Jude Medical201512—
+1K102721Livewire Electophysiology CatheterSt Jude Medical201014—
+1K061363Agilis NXT Steerable IntroducerSt Jude Medical2006531
+1K042074Vanguard Reprocessed Diagnostic Electrophysiology CathetersVanguard Medical Concepts, Inc.200501
+2K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+2K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…Surgical Instrument Service and Savings, Inc.20240Class I
+2K241370Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)Abbott Medical20244—
+2K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc.20230Class I
+2K203793RithmID-SD Steerable Diagnostic Electrophysiology CatheterSynaptic Medical Corporation20220—
+2K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+2K191190Steerable IntroducerFreudenberg Medical, LLC20190—
+2K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+2K182488Reprocessed Response Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+2K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC20170—
+2K170373Flextra Steerable IntroducerRhythm Xience, Inc. (Rxi)201744
+2K162427Vado Bi-Directional Steerable SheathKalila Medical, Inc.201701
+2K152090Reprocessed Steerable IntroducerSterilmed, Inc.20160Class I
+2K140420Vado Steerable SheathKalila Medical, Inc.20142—
+2K131079Creganna-Tactx Steerable Sheath Set SymmetricCreganna Medical Devices201304
+2K123334Reprocessed Steerable IntroducerStryker Sustainability Solutions, Inc.20130—
+2K110450Agilis NXT Steerable IntroducerSt Jude Medical20112—
+2K103083Agilis ES Steerable IntroducerSt Jude Medical20112—
+2K083402Agilis NXT Steerable Introducer, Model G408322 and G408323St Jude Medical20081—
+2K081645Agilis NXT Steerable Introducer, Model G408324St Jude Medical200836—
+2K083083Agilis NXT Steerable IntroducerSt Jude Medical20080—
+3K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+3K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+3K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+3K243493Agilis NxT Steerable Introducer Dual-ReachAbbott Medical20243—
+3K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+3K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+3K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC20230—
+3K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+3K221655Multiflex Steerable SheathVizaramed, Inc.20221—
+3K211530PathBuilder Steerable IntroducerShanghai Microport EP Medtech Co., Ltd.20220—
+3K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+3K210185CardioCurve Steerable SheathTalon Surgical20211—
+3K203459SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC20212—
+3K193509AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc.20203—
+3K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+3K170997CARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc.201737
+3K160721Vado Steerable SheathKalila Medical, Inc.201701
+3K151936Steerable Intracardiac Catheter Introducer Kit and Transseptal NeedleSynaptic Medical Limited20151—
+3K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+3K101784Mobicath BI-Directional Guiding Sheath Model 1000182-XXXGreat Batch Medical201003
+4K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+4K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.20260—
+4K260626Multiflex Steerable Sheath 17.5FVizaramed, Inc.20260—
+4K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+4K240600SafeCross Vascular Introducer System (4001)East End Medical I, LLC20240—
+4K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)Synaptic Medical Corporation20240—
+4K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath…Circa Scientific, Inc.20240—
+4K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc.20230—
+4K231412CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)Biosense Webster, Inc.20230—
+4K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC20220—
+4K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+4K210685AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20212—
+4K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+4K151951Destino ReachOscor, Inc.20156—
+5K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+5K233691FlexCath Cross Transseptal SolutionAcutus Medical, Inc.20230—
+5K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+5K220047AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20220—
+6K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—
+6K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+7K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+8K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+8K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+9K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—