510(k) Report

Devices descending from K031161

9 later devices reach Variable Lasso 2515 Circular Mapping Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112292Reprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions201105
+1K081258Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc.20097—
+1K082023Reprocessed Electrophysiology CathetersAscent Healthcare Solutions20081—
+2K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC20160—
+2K113213Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Biosense Webster, Inc.201141
+2K093376Lasso Nav CatheterBiosense Webster, Inc.20105—
+3K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology…CathRx, Ltd.20220—
+3K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, Inc.20160—
+3K130602Lasso Nav Duo Loop CatheterBiosense Webster, Inc.201301