510(k) Report

Devices descending from K073326

16 later devices reach NRG Transseptal Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc.20233—
+1K213584Reprocessed NRG Transseptal NeedleInnovative Health, LLC20230—
+1K203459SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC20212—
+1K200060Reprocessed NRG Transseptal NeedleInnovative Health, LLC20201—
+1K150709ProTrack RF Anchor WireBaylis Medical Company, Inc.201571
+2K261745LightningWire Transseptal Puncture System (TPS)ElectroWire Medical20260—
+2K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.20260—
+2K242076VersaCross™ RF WireBaylis Medical Company20242—
+2K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…Circa Scientific, Inc.20242—
+2K240600SafeCross Vascular Introducer System (4001)East End Medical I, LLC20240—
+2K240900HOTWIRE™ RF GuidewireAtraverse Medical20242—
+3K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…Pressure Products Medical Device Manufacturing, LLC20260—
+3K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc.20251—
+3K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…Circa Scientific, Inc.20250—
+3K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc.20240—
+4K260292Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical20260—