510(k) Report

Devices descending from K834413

44 later devices reach Dilation Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+1K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+1K013139Stellartech Coagulation SystemStellartech Research Corp.200142—
+2K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+2K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+2K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+2K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+2K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+2K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+2K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+2K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+3K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+3K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+3K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+3K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+3K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+3K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+3K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+3K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+3K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+4K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+4K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+4K213627RF Vapor SystemAqua Medical, Inc.20212—
+4K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+4K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+4K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+4K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+4K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+4K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+4K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+4K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+4K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+4K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+5K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+5K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+5K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+6K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+6K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+7K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+7K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+8K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+9K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+10K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+11K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—