510(k) Report

Devices descending from K140318

3 later devices reach Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc.20250Class I
+1K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…Sterilmed, Inc.20160—
+1K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—