510(k) Report

Devices descending from K051168

39 later devices reach Barrx Halo 360 System, Model 1100C-115A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101825Cryoballoon Ablation SystemC2 Therapeutics201011—
+1K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+1K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+1K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+1K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+1K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+1K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+1K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+1K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+2K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+2K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+2K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+2K131523Cryoballoon Focal Ablation SystemC2 Therapeutics2013102
+2K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+2K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+2K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+2K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+2K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+2K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+3K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+3K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+3K213627RF Vapor SystemAqua Medical, Inc.20212—
+3K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+3K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+3K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+3K160994C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc.20160—
+3K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+3K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+3K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+3K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc.20158—
+3K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+3K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+4K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+4K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+4K153541Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc.20160—
+5K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+6K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+7K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+8K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—