510(k) Report

Devices descending from K070242

14 later devices reach Soundstar 3D Ultrasound Catheter, Model M-5723-05 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc.20115—
+1K110076Reprocessed 3D Diagnostic Ultrasound CatheterSterilmed, Inc.201111
+1K091352Soundstar 3D Diagnostic Catheter, Model M-5723-05Biosense Webster, Inc.20091—
+1K092425Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10Ascent Healthcare Solutions20090—
+1K092064Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc.20099—
+2K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+2K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc.20250Class I
+2K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc.20241—
+2K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20231—
+2K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC20170—
+2K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…Sterilmed, Inc.20160—
+2K101138Soundstar 3D Ultrasound Catheter Model M-5723-12Biosense Webster, Inc.20101—
+3K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc.20260—
+3K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20240—