510(k) Report

Devices descending from K070417

11 later devices reach Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181088TSP Crosser Transseptal Access SystemTransseptal Solutions, Ltd.20180—
+1K132943Intracardic Catheter Introducer Kit and Transseptal NeedleSynaptic Medical Limited20140—
+1K072278BRK Transseptal NeedleSt Jude Medical20078—
+2K192998Reprocessed BRK Transseptal NeedleInnovative Health, LLC20200—
+2K122587BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical20136—
+2K111644Mobicath Transseptal NeedleGreat Batch Medical20110—
+3K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.20220—
+3K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC20181—
+3K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC20181—
+4K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC20240—
+4K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC20210—