Devices descending from K012083
89 later devices reach Attain Access 6218 Left-Heart Delivery System, Model 6218 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K053400 | Acumen Single-Lumen Delivery Sheath | Acumen Medical, Inc. | 2006 | 11 | — |
| +1 | K052459 | 6248VAL Adjustable Valve | Medtronic Vascular | 2006 | 0 | 1 |
| +1 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | 37 | — |
| +1 | K023937 | Cook Vascular Serpenta Coronary Sinus Introducer System | Cook Vascular, Inc. | 2003 | 0 | — |
| +1 | K021587 | Attain LDS 6216A Left-Heart Delivery System, Model 6216A | Medtronic Vascular | 2002 | 31 | 1 |
| +1 | K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218 | Medtronic Vascular | 2002 | 31 | 1 |
| +1 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | 80 | — |
| +2 | K112917 | Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery… | Medtronic, Inc. | 2011 | 0 | — |
| +2 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters… | Medtronic, Inc. | 2008 | 13 | — |
| +2 | K080500 | Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7 | Acumen Medical, Inc. | 2008 | 9 | — |
| +2 | K070396 | Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45 | Acumen Medical, Inc. | 2007 | 10 | — |
| +2 | K061416 | Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-XS59 &… | Medtronic Vascular | 2006 | 1 | — |
| +2 | K061480 | Attain 6227DEF Deflectable Catheter Delivery System | Medtronic, Ireland | 2006 | 0 | — |
| +2 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | 14 | — |
| +2 | K053277 | CPS Direct SL Outer Catheter | St Jude Medical | 2006 | 0 | 1 |
| +2 | K043489 | Enpath Deflectable Catheter | Enpath Medical Incorporated | 2005 | 13 | 2 |
| +2 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | 17 | — |
| +2 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | 35 | — |
| +2 | K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYS | Medtronic Vascular | 2003 | 5 | — |
| +2 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | 29 | — |
| +2 | K024032 | Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart Delivery | Medtronic Vascular | 2002 | 14 | — |
| +3 | K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | 2020 | 0 | — |
| +3 | K183493 | SelectSite C304-HIS Deflectable Catheter System | Medtronic, Inc. | 2019 | 0 | 1 |
| +3 | K123153 | Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for… | Medtronic, Ireland | 2013 | 3 | — |
| +3 | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | 8 | 1 |
| +3 | K100135 | GDS-DC12 | Guided Delivery Systems | 2010 | 0 | — |
| +3 | K090999 | Biocardia Morph Sheath Guide | Biocardia, Inc. | 2009 | 0 | 3 |
| +3 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart… | Medtronic, Inc. | 2009 | 12 | — |
| +3 | K082670 | Modification to: Attain Prevail 6228CTH80 Steerable Catheter Set | Medtronic, Inc. | 2008 | 0 | — |
| +3 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 30 | 1 |
| +3 | K070238 | Amplatzer Reliant Catheter Delivery System | Aga Medical Corp. | 2007 | 0 | — |
| +3 | K061119 | Enpath Medical Steerable Sheath | Enpath Medical, Inc. | 2006 | 10 | — |
| +3 | K053217 | CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147… | St Jude Medical | 2006 | 0 | 5 |
| +3 | K052575 | Luminary Cannulator Bideflectable Catheter with Lumen | St Jude Medical | 2006 | 4 | — |
| +3 | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | 3 | — |
| +4 | K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026 | 0 | — |
| +4 | K202610 | Ventrax Delivery System | Merit Medical Systems, Inc. | 2020 | 2 | — |
| +4 | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left… | Medtronic, Inc. | 2020 | 1 | — |
| +4 | K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery… | Centerpoint Systems | 2019 | 5 | — |
| +4 | K190581 | Amplatzer Trevisio Intravascular Delivery System | Abbott Medical | 2019 | 2 | — |
| +4 | K171819 | Attain Assist CS Access Catheter | Creganna Medical Also Doing Business AS Ceganna Tactx Medica | 2018 | 0 | — |
| +4 | K131063 | Amplatzer Torq Vue LP Delivery System | St Jude Medical | 2013 | 5 | 1 |
| +4 | K122960 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | 7 | — |
| +4 | K121611 | Amplatzer Torqvue FX | Aga Medical Corporation | 2012 | 0 | Class I |
| +4 | K103083 | Agilis ES Steerable Introducer | St Jude Medical | 2011 | 2 | — |
| +4 | K100184 | Fustar Steerable Introducers | Lifetech Scientific (Shenzhen) Co., Ltd. | 2011 | 0 | — |
| +4 | K101784 | Mobicath BI-Directional Guiding Sheath Model 1000182-XXX | Great Batch Medical | 2010 | 0 | 3 |
| +4 | K093476 | Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120… | Aga Medical Corp. | 2010 | 0 | — |
| +4 | K091793 | Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54 | Aga Medical Corp. | 2009 | 0 | — |
| +4 | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100… | Aga Medical Corp. | 2009 | 10 | — |
| +4 | K080994 | Amplatzer Torqvue Exchange System | Aga Medical Corp. | 2008 | 1 | — |
| +4 | K080757 | Amplatzer Torqvue Low Profile Delivery System | Aga Medical Corp. | 2008 | 7 | — |
| +4 | K070051 | Acumen Insight Endocardial Visualization System | Acumen Medical, Inc. | 2007 | 0 | — |
| +4 | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | 1 | — |
| +5 | K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026 | 0 | — |
| +5 | K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026 | 0 | — |
| +5 | K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System… | Abbott Medical | 2026 | 0 | — |
| +5 | K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025 | 0 | — |
| +5 | K241538 | TriClip Steerable Guide Catheter | Abbott Medical | 2024 | 1 | — |
| +5 | K231246 | Ventrax™ Delivery System (VTR851) | Merit Medical Systems, Inc. | 2023 | 1 | — |
| +5 | K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | 2023 | 3 | — |
| +5 | K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | Medtronic | 2022 | 0 | — |
| +5 | K212738 | Amplatzer Talisman Delivery Sheath | Abbott Medical | 2021 | 0 | — |
| +5 | K180864 | WATCHMAN TruSeal Access System | Boston Scientific | 2018 | 2 | Class I |
| +5 | K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2018 | 1 | — |
| +5 | K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016 | 4 | — |
| +5 | K162228 | TorqVue Low Profile Delivery Catheter | Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor | 2016 | 2 | 1 |
| +5 | K151951 | Destino Reach | Oscor, Inc. | 2015 | 6 | — |
| +5 | K120120 | Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer… | Aga Medical Corporation | 2012 | 5 | — |
| +5 | K062340 | Cardiooptics Augmentative Cardiac Optical Imaging System | Cardio-Optics, Inc. | 2006 | 0 | — |
| +6 | K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | Abbott Medical | 2025 | 0 | — |
| +6 | K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025 | 0 | — |
| +6 | K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025 | 1 | — |
| +6 | K242873 | Ventrax™ Delivery System | Merit Medical Systems, Inc. | 2025 | 0 | — |
| +6 | K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter… | Abbott Medical | 2024 | 0 | — |
| +6 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | 5 | — |
| +6 | K212026 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2021 | 3 | 1 |
| +6 | K212228 | WATCHMAN FXD Curve Access System | Boston Scientific Corporation | 2021 | 1 | Class I |
| +6 | K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2019 | 0 | — |
| +7 | K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026 | 0 | — |
| +7 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | 4 | — |
| +7 | K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | 2024 | 0 | Class I |
| +7 | K220340 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2022 | 2 | Class I |
| +8 | K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025 | 3 | — |
| +8 | K232690 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2023 | 1 | — |
| +9 | K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026 | 1 | — |
| +9 | K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026 | 0 | — |
| +9 | K250426 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2025 | 0 | — |
| +10 | K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026 | 0 | — |