510(k) Report

Devices descending from K050217

39 later devices reach Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140733Constellation Multiple Electrode Recording & Pacing CatheterBoston Scientific Corporation20143—
+1K120425Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc.2012345
+2K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.201821—
+2K170819AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.20172—
+2K123837Pentaray Nav Eco High-Density Mapping CatheterBiosense Webster, Inc.2013115
+3K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™Abbott Medical20243—
+3K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20210—
+3K201806Reprocessed PentaRay Nav eco High-Density Mapping CatheterSterilmed Inc. (Johnson and Johnson)20210—
+3K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+3K201341AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.20201—
+3K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20201—
+3K201750Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc.20205—
+3K193237Carto Octaray Mapping Catheter with Trueref TechnologyBiosense Webster, Inc.20202—
+3K190785Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative Health, LLC20190—
+4K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+4K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic20240—
+4K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc.20233—
+4K210766AcQMap 3D Imaging and Mapping Catheter, Model 900009Acutus Medical, Inc.20220—
+4K211438OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster, Inc.20221—
+4K212061EnSite X EP SystemAbbott202113—
+5K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+5K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+5K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren20240Class I
+5K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+5K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—
+5K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, Inc.20230—
+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—