510(k) Report

Devices descending from K083711

17 later devices reach Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+1K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+1K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+2K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+2K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+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
+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—
+3K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+3K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+3K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—