510(k) Report

Devices descending from K954390

33 later devices reach Cordis Wester Star Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081258Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc.20097—
+1K080425CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc.20087—
+1K070242Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc.200714—
+1K061463Esophageal Mapping Catheter, Model D-1272-01-SBiosense Webster, Inc.20060—
+1K052083Navistar RMT Steerable Tip Diagnostic CatheterBiosense Webster, Inc.20050—
+2K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+2K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc.20233—
+2K180710Reprocessed DecaNav Diagnostic Electrophysiology CatheterInnovative Health, LLC20180—
+2K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC20160—
+2K113213Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Biosense Webster, Inc.201141
+2K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc.20115—
+2K112292Reprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions201105
+2K110076Reprocessed 3D Diagnostic Ultrasound CatheterSterilmed, Inc.201111
+2K093376Lasso Nav CatheterBiosense Webster, Inc.20105—
+2K091352Soundstar 3D Diagnostic Catheter, Model M-5723-05Biosense Webster, Inc.20091—
+2K092425Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10Ascent Healthcare Solutions20090—
+2K091780Guided Measurement Catheter (GMC)Mediguide, Ltd.20091—
+2K092064Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc.20099—
+3K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+3K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc.20250Class I
+3K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren20240Class I
+3K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc.20241—
+3K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—
+3K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20231—
+3K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology…CathRx, Ltd.20220—
+3K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC20170—
+3K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…Sterilmed, Inc.20160—
+3K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, Inc.20160—
+3K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterSt Jude Medical20140—
+3K130602Lasso Nav Duo Loop CatheterBiosense Webster, Inc.201301
+3K101138Soundstar 3D Ultrasound Catheter Model M-5723-12Biosense Webster, Inc.20101—
+4K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc.20260—
+4K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20240—