Devices descending from K050389
164 later devices reach Ultra-Soft SV Balloon Dilatation Catheter through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +4 | K112281 | Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX | Trireme Medical, Inc. | 2011 | 4 | — |
| +5 | K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter | Zylox Medtech Co., Ltd. | 2026 | 0 | — |
| +5 | K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026 | 0 | — |
| +5 | K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2025 | 0 | — |
| +5 | K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | 2025 | 1 | — |
| +5 | K240653 | SmartCardia 7L Platform (MCT) | Smartcardia SA | 2024 | 1 | — |
| +5 | K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024 | 0 | — |
| +5 | K230263 | Finesse™ Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | 2023 | 0 | 1 |
| +5 | K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2022 | 2 | — |
| +5 | K220410 | Ebony HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2022 | 0 | — |
| +5 | K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2020 | 0 | — |
| +5 | K191275 | All’InCath 035M PTA Balloon Dilatation Catheter | Nexstep Medical | 2020 | 0 | — |
| +5 | K190037 | Cronus HP PTA Balloon Catheter | Nipro Medical Corporation | 2019 | 0 | — |
| +5 | K172494 | PROTEUS PTA Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2017 | 1 | — |
| +5 | K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017 | 1 | — |
| +5 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector… | Shockwave Medical, Inc. | 2016 | 10 | — |
| +5 | K143093 | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) | Hotspur Technologies, Inc., | 2015 | 0 | — |
| +5 | K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015 | 6 | — |
| +5 | K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Angioscore, Inc. | 2015 | 16 | — |
| +5 | K142300 | Arrow GPSCath Balloon Dialation Catheter (150 cm) | Hotspur Technologies, Inc., | 2014 | 1 | — |
| +5 | K132810 | Gladiator Elite Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2014 | 1 | — |
| +5 | K130414 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon… | Trireme Medical, Inc. | 2013 | 1 | — |
| +5 | K131329 | Vector Pta Balloon Dilatation Catheter | R4 Vascular, Inc. | 2013 | 1 | — |
| +5 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | 28 | — |
| +5 | K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corporation | 2012 | 9 | 2 |
| +6 | K260246 | SEISMIQ™ Intravascular Lithotripsy System | Bolt Medical, Inc. | 2026 | 0 | — |
| +6 | K260012 | UltraScore™ Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2026 | 0 | — |
| +6 | K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026 | 0 | — |
| +6 | K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2024 | 0 | — |
| +6 | K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2024 | 1 | — |
| +6 | K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040… | Goodman Co., Ltd. | 2024 | 1 | — |
| +6 | K213631 | Chocolate PTA Balloon Catheter | Medtronic, Inc. | 2021 | 0 | — |
| +6 | K201333 | SABER .035 PTA Dilatation Catheter | Cordis Corporation | 2020 | 1 | — |
| +6 | K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | 2020 | 2 | — |
| +6 | K193181 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020 | 1 | — |
| +6 | K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection | Contego Medical, LLC | 2018 | 0 | — |
| +6 | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular… | Shockwave Medical, Inc. | 2018 | 4 | — |
| +6 | K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2018 | 4 | 1 |
| +6 | K163380 | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2017 | 2 | — |
| +6 | K143652 | Vector PTA Balloon Dilatation Catheter | Vector Corporation, LLC | 2015 | 0 | — |
| +6 | K141597 | Mustang Balloon Dialation Catheter | Boston Scientific Corporation | 2014 | 0 | — |
| +6 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 6 | 1 |
| +7 | K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 2025 | 0 | — |
| +7 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters… | Biotronik, Inc. | 2025 | 0 | — |
| +7 | K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022 | 0 | — |
| +7 | K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | 2022 | 1 | — |
| +7 | K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL… | Shockwave Medical, Inc. | 2022 | 1 | — |
| +7 | K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2021 | 1 | — |
| +7 | K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | Cordis Corporation | 2021 | 0 | — |
| +7 | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL… | Shockwave Medical, Inc. | 2021 | 1 | — |
| +7 | K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020 | 0 | — |
| +7 | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable… | Shockwave Medical, Inc. | 2019 | 3 | — |
| +7 | K151153 | Pirouette 018 | Arravasc Limited | 2015 | 4 | — |
| +8 | K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral… | Shockwave Medical, Inc. | 2024 | 0 | — |
| +8 | K232258 | XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | 2024 | 0 | — |
| +8 | K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL… | Shockwave Medical, Inc. | 2024 | 0 | — |
| +8 | K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL… | Shockwave Medical, Inc. | 2024 | 1 | — |
| +8 | K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2022 | 0 | — |
| +8 | K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2022 | 0 | — |
| +8 | K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2017 | 1 | — |
| +8 | K162316 | Pirouette 014 | Arravasc, Ltd. | 2016 | 2 | — |
| +8 | K161427 | Pirouette 035 | Arravasc Limited | 2016 | 2 | — |
| +9 | K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL… | Shockwave Medical, Inc. | 2026 | 0 | — |
| +9 | K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2019 | 0 | — |