Devices descending from K964518
92 later devices reach Fast-Cath Transseptal Catheter Introducer through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K212626 | PathBuilder Transseptal Guiding Introducer | Shanghai Microport EP Medtech Co., Ltd. | 2022 | 0 | — |
| +1 | K181031 | TSI Transseptal Introducer | Pressure Products Medical Device Manufacturing, LLC | 2018 | 0 | 1 |
| +1 | K061015 | Fast-Cath Hemostasis Introducer and Transseptal Introducer | St Jude Medical | 2006 | 9 | — |
| +1 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | 36 | — |
| +1 | K043084 | Premere Delivery Sheath, Model PDS | Velocimed, Inc. | 2005 | 9 | — |
| +1 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 81 | 1 |
| +1 | K040552 | Model 3100 Series Sheath Introducer Kits, Models 3110, 3130 | Cryocor, Inc. | 2004 | 0 | — |
| +1 | K022067 | Convoy Advanced Delivery Sheath | Boston Scientific | 2002 | 13 | 1 |
| +1 | K983940 | EZ-Intro Percutaneous Catheter Sheath, EZ-Intro Vessel Dilator | Adam Spence Corp. | 1999 | 0 | — |
| +2 | K190941 | BioCardia 8.5 F Avance Steerable lntroducer | Biocardia, Inc. | 2019 | 1 | — |
| +2 | K171081 | Guider Catheter Introducer | Rhythm Xience, Inc. (Rxi) | 2017 | 4 | — |
| +2 | K120086 | Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable… | Cardiosolutions | 2012 | 2 | — |
| +2 | K101497 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2010 | 8 | 30 |
| +2 | K083793 | Steerable Guide Catheter | Evalve, Inc. | 2009 | 8 | — |
| +2 | K072719 | Convoy Advanced Delivery Sheath | Boston Scientific Corp | 2008 | 11 | 1 |
| +2 | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982… | St Jude Medical | 2007 | 11 | — |
| +2 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 53 | 1 |
| +2 | K034061 | Modification to Convoy Advanced Delivery Sheath | Boston Scientific Corp | 2004 | 12 | 1 |
| +3 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid… | Abbott Medical | 2025 | 2 | — |
| +3 | K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) | Abbott Medical | 2024 | 4 | — |
| +3 | K202226 | Lim Precision Steerable TS, Steerable Sheath, Dilator | Keystone Heart, Ltd. | 2020 | 0 | — |
| +3 | K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | Acutus Medical, Inc. | 2020 | 3 | — |
| +3 | K191190 | Steerable Introducer | Freudenberg Medical, LLC | 2019 | 0 | — |
| +3 | K181088 | TSP Crosser Transseptal Access System | Transseptal Solutions, Ltd. | 2018 | 0 | — |
| +3 | K170311 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | 2017 | 0 | — |
| +3 | K170373 | Flextra Steerable Introducer | Rhythm Xience, Inc. (Rxi) | 2017 | 4 | 4 |
| +3 | K162427 | Vado Bi-Directional Steerable Sheath | Kalila Medical, Inc. | 2017 | 0 | 1 |
| +3 | K161985 | Steerable Guide Catheter | Abbott Vascular | 2016 | 0 | — |
| +3 | K152090 | Reprocessed Steerable Introducer | Sterilmed, Inc. | 2016 | 0 | Class I |
| +3 | K132943 | Intracardic Catheter Introducer Kit and Transseptal Needle | Synaptic Medical Limited | 2014 | 0 | — |
| +3 | K140420 | Vado Steerable Sheath | Kalila Medical, Inc. | 2014 | 2 | — |
| +3 | K140015 | Cardiosolutions Dexterity Steerable Introducer | Cardiosolutions, Inc. | 2014 | 0 | — |
| +3 | K131079 | Creganna-Tactx Steerable Sheath Set Symmetric | Creganna Medical Devices | 2013 | 0 | 4 |
| +3 | K131332 | Cardiosolutions Percu-Pro Steerable Introducer | Cardiosolutions, Inc. | 2013 | 1 | — |
| +3 | K123334 | Reprocessed Steerable Introducer | Stryker Sustainability Solutions, Inc. | 2013 | 0 | — |
| +3 | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | 7 | — |
| +3 | K112239 | Steerable Guide Catheter | Abbott Vascular | 2011 | 1 | — |
| +3 | K110450 | Agilis NXT Steerable Introducer | St Jude Medical | 2011 | 2 | — |
| +3 | K103083 | Agilis ES Steerable Introducer | St Jude Medical | 2011 | 2 | — |
| +3 | K100789 | Modificaton to: Steerable Guide Catheter, Model SGC01ST | Evalve, Inc. | 2010 | 5 | — |
| +3 | K093866 | Evalve Steerable Guide Catheter | Evalve, Inc. | 2010 | 6 | — |
| +3 | K091367 | GDS-DCS | Guided Delivery Systems | 2009 | 1 | — |
| +3 | K091596 | Evalve Steerable Guide Catheter, Model SGC01ST | Evalve, Inc. | 2009 | 7 | — |
| +3 | K083402 | Agilis NXT Steerable Introducer, Model G408322 and G408323 | St Jude Medical | 2008 | 1 | — |
| +3 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | 36 | — |
| +3 | K083083 | Agilis NXT Steerable Introducer | St Jude Medical | 2008 | 0 | — |
| +3 | K072278 | BRK Transseptal Needle | St Jude Medical | 2007 | 8 | — |
| +4 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026 | 0 | — |
| +4 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025 | 0 | — |
| +4 | K243493 | Agilis NxT Steerable Introducer Dual-Reach | Abbott Medical | 2024 | 3 | — |
| +4 | K230376 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | 2023 | 0 | — |
| +4 | K221655 | Multiflex Steerable Sheath | Vizaramed, Inc. | 2022 | 1 | — |
| +4 | K211530 | PathBuilder Steerable Introducer | Shanghai Microport EP Medtech Co., Ltd. | 2022 | 0 | — |
| +4 | K212026 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2021 | 3 | 1 |
| +4 | K210185 | CardioCurve Steerable Sheath | Talon Surgical | 2021 | 1 | — |
| +4 | K203459 | SafeCross Transseptal Puncture and Introducer (TSP/I) System | East End Medical I, LLC | 2021 | 2 | — |
| +4 | K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2021 | 2 | — |
| +4 | K192998 | Reprocessed BRK Transseptal Needle | Innovative Health, LLC | 2020 | 0 | — |
| +4 | K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2018 | 1 | — |
| +4 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | Biosense Webster, Inc. | 2017 | 3 | 7 |
| +4 | K160721 | Vado Steerable Sheath | Kalila Medical, Inc. | 2017 | 0 | 1 |
| +4 | K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle | Synaptic Medical Limited | 2015 | 1 | — |
| +4 | K151951 | Destino Reach | Oscor, Inc. | 2015 | 6 | — |
| +4 | K122587 | BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | 2013 | 6 | — |
| +4 | K111644 | Mobicath Transseptal Needle | Great Batch Medical | 2011 | 0 | — |
| +4 | K101784 | Mobicath BI-Directional Guiding Sheath Model 1000182-XXX | Great Batch Medical | 2010 | 0 | 3 |
| +4 | K100135 | GDS-DC12 | Guided Delivery Systems | 2010 | 0 | — |
| +5 | K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026 | 0 | — |
| +5 | K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026 | 0 | — |
| +5 | K240600 | SafeCross Vascular Introducer System (4001) | East End Medical I, LLC | 2024 | 0 | — |
| +5 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | 5 | — |
| +5 | K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | Synaptic Medical Corporation | 2024 | 0 | — |
| +5 | K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath… | Circa Scientific, Inc. | 2024 | 0 | — |
| +5 | K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Company, Inc. | 2023 | 0 | — |
| +5 | K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | 2023 | 0 | — |
| +5 | K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | Biosense Webster, Inc. | 2023 | 0 | — |
| +5 | K212625 | PathBuilder Transseptal Needle | Shanghai Microport EP Medtech Co., Ltd. | 2022 | 0 | — |
| +5 | K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Innovative Health, LLC | 2022 | 0 | — |
| +5 | K220340 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2022 | 2 | Class I |
| +5 | K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2022 | 0 | — |
| +5 | K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2019 | 0 | — |
| +5 | K172950 | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | 2018 | 1 | — |
| +5 | K172934 | Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC | 2018 | 1 | — |
| +6 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | 4 | — |
| +6 | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | 2024 | 0 | — |
| +6 | K232690 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2023 | 1 | — |
| +6 | K210328 | SafeSept Blunt Needle | Pressure Products Medical Device Manufacturing, LLC | 2021 | 0 | — |
| +7 | K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025 | 3 | — |
| +7 | K250426 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2025 | 0 | — |
| +8 | K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026 | 1 | — |
| +8 | K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026 | 0 | — |
| +9 | K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026 | 0 | — |