510(k) Report

Devices descending from K072278

8 later devices reach BRK Transseptal Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192998Reprocessed BRK Transseptal NeedleInnovative Health, LLC20200—
+1K122587BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical20136—
+1K111644Mobicath Transseptal NeedleGreat Batch Medical20110—
+2K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.20220—
+2K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC20181—
+2K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC20181—
+3K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC20240—
+3K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC20210—