510(k) Report

Devices descending from K011727

28 later devices reach Transseptal Needle/Trocar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111644Mobicath Transseptal NeedleGreat Batch Medical20110—
+1K073326NRG Transseptal NeedleBaylis Medical Co., Inc.2008161
+1K072278BRK Transseptal NeedleSt Jude Medical20078—
+1K061070Hansen Medical Transseptal Needle and DilatorHansen Medical, Inc.20061—
+2K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc.20233—
+2K213584Reprocessed NRG Transseptal NeedleInnovative Health, LLC20230—
+2K203459SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC20212—
+2K200060Reprocessed NRG Transseptal NeedleInnovative Health, LLC20201—
+2K192998Reprocessed BRK Transseptal NeedleInnovative Health, LLC20200—
+2K150709ProTrack RF Anchor WireBaylis Medical Company, Inc.201571
+2K122587BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical20136—
+2K082075Hansen Medical Dilator for Artisan Control CatheterHansen Medical, Inc.20080—
+3K261745LightningWire Transseptal Puncture System (TPS)ElectroWire Medical20260—
+3K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.20260—
+3K242076VersaCross™ RF WireBaylis Medical Company20242—
+3K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…Circa Scientific, Inc.20242—
+3K240600SafeCross Vascular Introducer System (4001)East End Medical I, LLC20240—
+3K240900HOTWIRE™ RF GuidewireAtraverse Medical20242—
+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—
+4K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…Pressure Products Medical Device Manufacturing, LLC20260—
+4K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc.20251—
+4K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…Circa Scientific, Inc.20250—
+4K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc.20240—
+4K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC20240—
+4K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC20210—
+5K260292Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical20260—