510(k) Report

Devices descending from K201775

2 later devices reach NuVision ICE Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20240—
+1K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20231—