510(k) Report

Devices descending from K043425

4 later devices reach Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083667Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide…B-K Medical Aps20093—
+2K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc.20162—
+3K262474ND Needle Guidance SystemAccurate Access, LLC20260—
+3K250524Mendaera Guidance SystemMendaera, Inc.20250—