510(k) Report

Devices descending from K863437

47 later devices reach Bard Balloon Dilatation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983220Stryker Infravision Esophageal KitStryker Endoscopy199912
+1K940965Eliminator Balloon DilatorC.R. Bard, Inc.199444—
+2K130906Endoflip CatheterCrospon, Ltd.20130—
+2K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+2K013139Stellartech Coagulation SystemStellartech Research Corp.200142—
+3K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+3K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+3K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+3K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+3K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+3K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+3K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+3K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+3K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+4K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+4K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+4K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+4K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+4K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+4K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+4K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+4K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+4K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+5K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+5K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+5K213627RF Vapor SystemAqua Medical, Inc.20212—
+5K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+5K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+5K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+5K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+5K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+5K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+5K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+5K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+5K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+5K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+6K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+6K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+6K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+7K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+7K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+8K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+8K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+9K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+10K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+11K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+12K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—