510(k) Report

Devices descending from K170263

6 later devices reach AcuNav Diagnostic Ultrasound Catheter 8F,10F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens…Surgical Instrument Service and Savings, Inc.20250—
+1K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…Surgical Instrument Service and Savings, Inc.20240Class I
+1K233270AcuNav Crystal Ultrasound CatheterSiemens Medical Solutions USA, Inc.20231—
+1K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterPhilips Image Guided Therapy Corporation20201—
+2K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…Sterilmed, Inc.20260—
+2K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…Philips Image Guided Therapy Corporation20250—