510(k) Report

Devices descending from K052644

36 later devices reach Swartz Braided Transseptal Guiding Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171081Guider Catheter IntroducerRhythm Xience, Inc. (Rxi)20174—
+1K083793Steerable Guide CatheterEvalve, Inc.20098—
+1K070417Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982…St Jude Medical200711—
+1K061015Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical20069—
+2K193509AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc.20203—
+2K181088TSP Crosser Transseptal Access SystemTransseptal Solutions, Ltd.20180—
+2K161985Steerable Guide CatheterAbbott Vascular20160—
+2K132943Intracardic Catheter Introducer Kit and Transseptal NeedleSynaptic Medical Limited20140—
+2K112239Steerable Guide CatheterAbbott Vascular20111—
+2K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010830
+2K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.20105—
+2K093866Evalve Steerable Guide CatheterEvalve, Inc.20106—
+2K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc.20097—
+2K072278BRK Transseptal NeedleSt Jude Medical20078—
+3K210685AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20212—
+3K192998Reprocessed BRK Transseptal NeedleInnovative Health, LLC20200—
+3K122587BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical20136—
+3K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+3K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Cardiosolutions20122—
+3K111644Mobicath Transseptal NeedleGreat Batch Medical20110—
+4K233691FlexCath Cross Transseptal SolutionAcutus Medical, Inc.20230—
+4K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.20220—
+4K220047AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20220—
+4K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC20181—
+4K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC20181—
+4K151951Destino ReachOscor, Inc.20156—
+4K140015Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc.20140—
+4K131332Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc.20131—
+5K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC20240—
+5K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+5K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC20210—
+6K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+7K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+8K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+8K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+9K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—