510(k) Report

Devices descending from K010471

41 later devices reach Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions20110—
+1K101789Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20100—
+1K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions20081—
+1K042775Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterIrvine Biomedical, Inc.200440—
+2K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…St Jude Medical201625—
+2K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry…Innovative Health, LLC20160—
+2K160496Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC20160—
+2K101623Inquiry Afocusii Diagnostic CatheterSt Jude Medical20100—
+2K082061Inquiry H-Curve TV Steerable Diagnostic CatheterIrvine Biomedical, Inc.20081—
+2K062251Reflexion Spiral Variable Radius Catheter, Model 402804St Jude Medical20065—
+2K060757Inquiry Optima Plus Steerable Electrophysiology CatheterIrvine Biomedical, Inc.20063—
+2K053582Inquiry Afocus II Diagnostic CatheterIrvine Biomedical, Inc.20061—
+3K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+3K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledStryker Sustainability Solutions20200—
+3K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical201918—
+3K181458Reprocessed Advisor FL Sensor Enabled Circular Mapping CatheterInnovative Health, LLC20180—
+3K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.201821—
+3K090323Reprocessed Electrophysiology CathetersAscent Healthcare Solutions20090—
+3K072012Reflexion Spiral Variable Radius CatheterSt Jude Medical20074—
+4K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+4K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™Abbott Medical20243—
+4K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20210—
+4K212061EnSite X EP SystemAbbott202113—
+4K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20201—
+4K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterInnovative Health, LLC20190—
+4K080179Reflexion HD High-Density Mapping CatheterSt Jude Medical200911
+5K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+5K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+5K213364EnSite X EP SystemAbbott Medical202112—
+6K221213EnSite X EP SystemAbbott202211—
+7K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+8K231415EnSite™ X EP SystemAbbott Medical20239—
+9K242016EnSite™ X EP SystemAbbott Medical20248—
+10K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+10K252013EnSite™ X EP SystemAbbott Medical20253—
+10K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+10K251234EnSite™ X EP SystemAbbott Medical20254—
+11K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+11K260212EnSite™ X EP SystemAbbott Medical20262—
+12K261729EnSite™ X EP SystemAbbott Medical20260—
+12K262006EnSite™ X EP SystemAbbott Medical20260—