| CPS Locator 3D Plus Delivery Catheter (K261766) | CenterPoint Systems, LLC | 2026-07-29 |
| SSPC NXT Delivery Catheter (K262240) | CenterPoint Systems, LLC | 2026-07-29 |
| Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825) | Abbott | 2026-07-02 |
| Amplatzer TorqVue Exchange System (K261631) | Abbott Medical | 2026-06-17 |
| Perfect-O Ostial Positioning Catheter (K260289) | Balosmark, Inc. | 2026-06-05 |
| Amplatzer TorqVue Delivery System (K260993) | Abbott | 2026-04-24 |
| Teleport Glide Microcatheter (K253361) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499) | ABBOTT MEDICAL | 2026-03-13 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |
| Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (K252417) | ABBOTT MEDICAL | 2025-12-17 |
| Telescope Guide Extension Catheter (K252390) | Medtronic, Ireland | 2025-10-29 |
| CPS Locator 3D Delivery Catheter (K250147) | Centerpoint Systems | 2025-08-22 |
| CoraForce Microcatheter, CoraFlex Microcatheter (K251277) | Reflow Medical, Inc. | 2025-08-22 |
| Primum Hydrophilic Guiding Catheter (K250972) | Pendracare | 2025-06-29 |
| CPS Locator 3D Plus Delivery Catheter (K250828) | CenterPoint Systems, LLC | 2025-06-27 |
| SAT CenterFlow Molding Balloon Catheter (IN20-00313) (K243184) | Strait Access Technologies Holdings | 2025-06-25 |
| FlexiGo 3D Delivery Catheter (K250492) | CenterPoint Systems, LLC | 2025-06-18 |
| Dorado™ PTA Balloon Dilatation Catheter (K250219) | Bard Peripheral Vascular, Inc. | 2025-06-17 |
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| Shockwave CS Guide Catheter (K243757) | Shockwave Medical, Inc. | 2025-05-02 |
| APRO 45 Catheter (K251014) | Alembic, LLC | 2025-05-01 |
| APRO 55 Intermediate Catheter (K250962) | Alembic, LLC | 2025-04-29 |
| Amulet™ Steerable Delivery Sheath (K250426) | ABBOTT MEDICAL | 2025-04-25 |
| FlowGuide (FG60F); GuidionShort (GS60F) (K242337) | Imds Operations B.V. | 2025-04-17 |
| LiquID .051 LP Guide Catheter Extension (K243691) | Seigla Medical, Inc. | 2025-04-04 |
| SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (K250558) | Medtronic, Inc. | 2025-03-27 |
| Seclusion Catheter (K243436) | Basis Medical | 2025-02-28 |
| Ventrax™ Delivery System (K242873) | Merit Medical Systems, Inc. | 2025-01-15 |
| COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (K242588) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 |
| MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) (K243224) | ABBOTT MEDICAL | 2024-12-31 |
| SENDERO MAX Delivery Catheter (K242644) | Okami Medical, Inc. | 2024-12-20 |
| Shadow Catheter (K240885) | Simpson Interventions, Inc. | 2024-12-19 |
| SSPC NXT Delivery Catheter (K243180) | CenterPoint Systems, LLC | 2024-12-04 |
| CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (K242276) | Vantis Vascular, Inc. | 2024-09-30 |
| Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (K240787) | Biotronik, Inc. | 2024-09-12 |
| ShapeIT (SI014135) (K241611) | Imds Operations B.V. | 2024-09-03 |
| TriClip Steerable Guide Catheter (K241538) | ABBOTT MEDICAL | 2024-08-26 |
| Cordis BRITECROSS Support Catheter (K233637) | Cordis US Corp | 2024-06-28 |
| ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 (K241158) | Asahi Intecc Co., Ltd. | 2024-06-25 |
| React 71 Catheter (K241177) | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2024-05-28 |
| APRO 55 Catheter (K234115) | Alembic, LLC | 2024-03-15 |
| SENDERO Microcatheter (K240384) | Okami Medical, Inc. | 2024-03-08 |
| SINC Support Catheter (K233350) | Reflow Medical, Inc. | 2024-02-08 |
| WATCHMAN TruSteer Access System (M635TU90050) (K240018) | Boston Scientific Corporation | 2024-02-01 |
| Teleport XT Microcatheter (K231608) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-01-07 |
| TriSalus TriGuideTM Guiding Catheter (K233858) | Trisalus Life Sciences | 2023-12-27 |
| SENDERO Microcatheter (K231600) | Okami Medical, Inc. | 2023-11-17 |
| 091 Balloon Guide Catheter (K231629) | Eosolutions, Corp. | 2023-10-31 |
| Paragon 8F Balloon Guide Catheter (K232437) | Wallaby Medical | 2023-10-13 |
| Microcatheter (K232647) | Surmodics,Inc. | 2023-09-29 |
| Amulet™ Steerable Delivery Sheath (K232690) | ABBOTT MEDICAL | 2023-09-29 |
| Ventrax™ Delivery System (VTR851) (K231246) | Merit Medical Systems, Inc. | 2023-08-30 |
| 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (K232190) | Medtronic Vascular | 2023-08-22 |
| Rubicon™ Control Support Catheter (H749394323506A1) (K223633) | Boston Scientific Corporation | 2023-08-08 |
| R2P Navicross (K231044) | Terumo Medical Corporation | 2023-07-27 |
| Micro Rx (K223728) | Imds Operations B.V. | 2023-07-13 |
| 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter (K230156) | Medtronic Vascular | 2023-06-30 |
| CPS Direct™ Universal slittable outer guide catheter (DS2C029) (K231311) | ABBOTT MEDICAL | 2023-06-02 |
| Stingray LP Catheter (K231176) | Boston Scientific | 2023-05-25 |
| RayFlow (K222023) | Hexacath | 2023-04-06 |
| CPS Locator 3D Delivery Catheter (K230363) | CenterPoint Systems, LLC | 2023-03-09 |
| 6F Wallaby Long Sheath (K222603) | Wallaby Medical, Inc. | 2023-03-02 |
| ISAAC Neurovascular Navigation Catheter (K222115) | MicroVention, Inc. | 2023-01-10 |
| SelectSite C304 Deflectable Catheter System, C315 Delivery System (K223178) | Medtronic | 2022-11-08 |
| Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system (K222873) | Medtronic | 2022-11-07 |
| Houdini Cross Support Catheter (K213466) | Cruzar Medsystems, Inc. | 2022-10-20 |
| Sublime Microcatheter (K221886) | Surmodics,Inc. | 2022-10-14 |
| SOFIA 88 Catheter (K214024) | MicroVention, Inc. | 2022-09-12 |
| GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) (K220647) | Vascular Solutions, LLC | 2022-08-18 |
| 091 Balloon Guide Catheter (K220331) | Inneuroco, Inc. | 2022-07-29 |
| Selectra Lead Implantation System (K222037) | Biotronik, Inc. | 2022-07-19 |
| Artix Ballon Guiding Sheath (K221846) | Inari Medical | 2022-07-11 |
| CPS AIM Universal II Slittable Inner Catheter (K221750) | ABBOTT MEDICAL | 2022-06-30 |
| Boss Crossing Support Catheter (K220632) | Marvao Medical Devices, Ltd. | 2022-06-02 |
| Spartan SC 069 (K220716) | Spartan Micro, Inc. | 2022-05-05 |
| LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension (K220691) | Seigla Medical, Inc. | 2022-05-05 |
| Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter (K212588) | C.R. Bard, Inc. | 2022-05-04 |
| XO CROSS CORONARY Support Catheter (K214107) | Transit Scientific, LLC | 2022-04-11 |
| Amplatzer Steerable Delivery Sheath (K220340) | ABBOTT MEDICAL | 2022-03-09 |
| Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter (K212211) | Vascular Solutions, LLC | 2022-02-09 |
| QuikPass Catheter (K214106) | Traverse Vascular, Inc. | 2022-01-28 |
| Guiding Catheter (K210009) | CenterPoint Systems, LLC | 2021-11-24 |
| XO Cross Support Catheter (K210322) | Transit Scientific, LLC | 2021-10-21 |
| Amplatzer Talisman Delivery Sheath (K212738) | ABBOTT MEDICAL | 2021-09-27 |
| Amplatzer Steerable Delivery Sheath (K212026) | ABBOTT MEDICAL | 2021-09-27 |
| ViperCross Support Catheters (K212725) | Cardiovascular Systems, Inc. | 2021-09-24 |
| ViperCross Support Catheters (K211240) | Cardiovascular Systems, Inc. | 2021-08-26 |
| WATCHMAN FXD Curve Access System (K212228) | Boston Scientific Corporation | 2021-08-13 |
| Rist 071 Radial Access Guide Catheter (K211990) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-27 |
| ReCross (K210431) | Imds Operations B.V. | 2021-07-15 |
| Arterial Catheter (K201726) | Haolang Medical USA Corporation | 2021-07-07 |
| coraCross (K210188) | Reflow Medical | 2021-05-28 |
| ViperCath XC Peripheral Exchange Catheter (K211251) | Cardiovascular Systems, Inc. | 2021-05-26 |
| SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter (K210647) | Vascular Solutions, LLC | 2021-04-30 |
| Plato 17 Microcatheter (K210601) | Scientia Vascular, LLC | 2021-04-28 |
| Guidion (K210110) | Imds Operations B.V. | 2021-03-31 |
| FineCross M3 (K203521) | Ashitaka Factory of Terumo Corporation | 2021-03-03 |
| Recon Support Catheter (K203275) | C.R. Bard, Inc. | 2021-03-01 |
| Phenom Catheters (K210230) | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2021-02-25 |
| Ventrax Delivery System (K202610) | Merit Medical Systems, Inc. | 2020-12-14 |