510(k) Report

Devices descending from K931403

18 later devices reach Siterite Needle Guide (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043425Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based…Sheathing Technologies, Inc.20054—
+1K042445Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc.200412—
+2K171348Pinpoint GT Needle Guide KitsC.R. Bard, Inc.20172—
+2K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+2K083667Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide…B-K Medical Aps20093—
+3K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc.20251—
+3K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc.20162—
+3K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+3K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+4K262474ND Needle Guidance SystemAccurate Access, LLC20260—
+4K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.20260—
+4K250524Mendaera Guidance SystemMendaera, Inc.20250—
+4K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+4K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+5K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+5K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+6K251673X9 Ultrasound SystemX9, Inc.20250—
+6K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—