510(k) Report

Devices descending from K083737

22 later devices reach Halo Ablation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+1K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+1K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+1K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+2K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+2K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+2K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+2K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+2K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+2K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+2K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+2K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+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—
+3K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+3K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+3K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+4K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+5K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+6K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—