510(k) Report

Devices descending from K092064

9 later devices reach Soundstar 3D Ultrasound Catheter, Model M-5723-12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+1K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc.20115—
+1K101138Soundstar 3D Ultrasound Catheter Model M-5723-12Biosense Webster, Inc.20101—
+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—
+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—