510(k) Report

Devices descending from K160335

25 later devices reach Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+1K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledStryker Sustainability Solutions20200—
+1K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical201918—
+1K181458Reprocessed Advisor FL Sensor Enabled Circular Mapping CatheterInnovative Health, LLC20180—
+1K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.201821—
+2K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+2K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™Abbott Medical20243—
+2K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20210—
+2K212061EnSite X EP SystemAbbott202113—
+2K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20201—
+3K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+3K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+3K213364EnSite X EP SystemAbbott Medical202112—
+4K221213EnSite X EP SystemAbbott202211—
+5K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+6K231415EnSite™ X EP SystemAbbott Medical20239—
+7K242016EnSite™ X EP SystemAbbott Medical20248—
+8K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+8K252013EnSite™ X EP SystemAbbott Medical20253—
+8K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+8K251234EnSite™ X EP SystemAbbott Medical20254—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K260212EnSite™ X EP SystemAbbott Medical20262—
+10K261729EnSite™ X EP SystemAbbott Medical20260—
+10K262006EnSite™ X EP SystemAbbott Medical20260—