510(k) Report

Devices descending from K163259

4 later devices reach AXS Offset Delivery Assist Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172014Wedge MicrocatheterMicroVention, Inc.20183—
+2K232542Wedge XL Delivery CatheterMicroVention, Inc.20240—
+2K230609NG Delivery CatheterBalt USA, LLC20231—
+3K252569Carrier XL Delivery CatheterBalt USA, LLC20250—