DQY · Catheter, Percutaneous
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | DQY |
|---|---|
| Device Name | Catheter, Percutaneous |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Cleared Devices (887)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Apr 10, 2026 | SESE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | Mar 13, 2026 | SESE |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | Dec 19, 2025 | SESE |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | Dec 17, 2025 | SESE |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | Oct 29, 2025 | SESE |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | Aug 22, 2025 | SESE |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | Aug 22, 2025 | SESE |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | Jun 29, 2025 | SESE |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | Jun 27, 2025 | SESE |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | Jun 25, 2025 | SESE |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | Jun 18, 2025 | SESE |
| K250219 | Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | Jun 17, 2025 | SESE |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | Jun 2, 2025 | SESE |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | May 2, 2025 | SESE |
| K251014 | APRO 45 Catheter | Alembic, LLC | May 1, 2025 | SESE |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | Apr 29, 2025 | SESE |
| K250426 | Amulet Steerable Delivery Sheath | ABBOTT MEDICAL | Apr 25, 2025 | SESE |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | Apr 17, 2025 | SESE |
| K243691 | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | Apr 4, 2025 | SESE |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. | Mar 27, 2025 | SESE |
| K243436 | Seclusion Catheter | Basis Medical | Feb 28, 2025 | SESE |
| K242873 | Ventrax Delivery System | Merit Medical Systems, Inc. | Jan 15, 2025 | SESE |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. | Jan 7, 2025 | SESE |
| K243224 | MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) | ABBOTT MEDICAL | Dec 31, 2024 | SESE |
| K242644 | SENDERO MAX Delivery Catheter | Okami Medical, Inc. | Dec 20, 2024 | SESE |
| K240885 | Shadow Catheter | Simpson Interventions, Inc. | Dec 19, 2024 | SESE |
| K243180 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | Dec 4, 2024 | SESE |
| K242276 | CrossFAST Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. | Sep 30, 2024 | SESE |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | Biotronik, Inc. | Sep 12, 2024 | SESE |
| K241611 | ShapeIT (SI014135) | Imds Operations B.V. | Sep 3, 2024 | SESE |
| K241538 | TriClip Steerable Guide Catheter | ABBOTT MEDICAL | Aug 26, 2024 | SESE |
| K233637 | Cordis BRITECROSS Support Catheter | Cordis US Corp | Jun 28, 2024 | SESE |
| K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 | Asahi Intecc Co., Ltd. | Jun 25, 2024 | SESE |
| K241177 | React 71 Catheter | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | May 28, 2024 | SESE |
| K234115 | APRO 55 Catheter | Alembic, LLC | Mar 15, 2024 | SESE |
| K240384 | SENDERO Microcatheter | Okami Medical, Inc. | Mar 8, 2024 | SESE |
| K233350 | SINC Support Catheter | Reflow Medical, Inc. | Feb 8, 2024 | SESE |
| K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | Feb 1, 2024 | SESE |
| K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Jan 7, 2024 | SESE |
| K233858 | TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences | Dec 27, 2023 | SESE |
| K231600 | SENDERO Microcatheter | Okami Medical, Inc. | Nov 17, 2023 | SESE |
| K231629 | 091 Balloon Guide Catheter | Eosolutions, Corp. | Oct 31, 2023 | SESE |
| K232437 | Paragon 8F Balloon Guide Catheter | Wallaby Medical | Oct 13, 2023 | SESE |
| K232690 | Amulet Steerable Delivery Sheath | ABBOTT MEDICAL | Sep 29, 2023 | SESE |
| K232647 | Microcatheter | Surmodics,Inc. | Sep 29, 2023 | SESE |
| K231246 | Ventrax Delivery System (VTR851) | Merit Medical Systems, Inc. | Aug 30, 2023 | SESE |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | Medtronic Vascular | Aug 22, 2023 | SESE |
| K223633 | Rubicon Control Support Catheter (H749394323506A1) | Boston Scientific Corporation | Aug 8, 2023 | SESE |
| K231044 | R2P Navicross | Terumo Medical Corporation | Jul 27, 2023 | SESE |
| K223728 | Micro Rx | Imds Operations B.V. | Jul 13, 2023 | SESE |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | Medtronic Vascular | Jun 30, 2023 | SESE |
| K231311 | CPS Direct Universal slittable outer guide catheter (DS2C029) | ABBOTT MEDICAL | Jun 2, 2023 | SESE |
| K231176 | Stingray LP Catheter | Boston Scientific | May 25, 2023 | SESE |
| K222023 | RayFlow | Hexacath | Apr 6, 2023 | SESE |
| K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | Mar 9, 2023 | SESE |
| K222603 | 6F Wallaby Long Sheath | Wallaby Medical, Inc. | Mar 2, 2023 | SESE |
| K222115 | ISAAC Neurovascular Navigation Catheter | MicroVention, Inc. | Jan 10, 2023 | SESE |
| K223178 | SelectSite C304 Deflectable Catheter System, C315 Delivery System | Medtronic | Nov 8, 2022 | SESE |
| K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | Medtronic | Nov 7, 2022 | SESE |
| K213466 | Houdini Cross Support Catheter | Cruzar Medsystems, Inc. | Oct 20, 2022 | SESE |
| K221886 | Sublime Microcatheter | Surmodics,Inc. | Oct 14, 2022 | SESE |
| K214024 | SOFIA 88 Catheter | MicroVention, Inc. | Sep 12, 2022 | SESE |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | Vascular Solutions, LLC | Aug 18, 2022 | SESE |
| K220331 | 091 Balloon Guide Catheter | Inneuroco, Inc. | Jul 29, 2022 | SESE |
| K222037 | Selectra Lead Implantation System | Biotronik, Inc. | Jul 19, 2022 | SESE |
| K221846 | Artix Ballon Guiding Sheath | Inari Medical | Jul 11, 2022 | SESE |
| K221750 | CPS AIM Universal II Slittable Inner Catheter | ABBOTT MEDICAL | Jun 30, 2022 | SESE |
| K220632 | Boss Crossing Support Catheter | Marvao Medical Devices, Ltd. | Jun 2, 2022 | SESE |
| K220716 | Spartan SC 069 | Spartan Micro, Inc. | May 5, 2022 | SESE |
| K220691 | LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension | Seigla Medical, Inc. | May 5, 2022 | SESE |
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | May 4, 2022 | SESE |
| K214107 | XO CROSS CORONARY Support Catheter | Transit Scientific, LLC | Apr 11, 2022 | SESE |
| K220340 | Amplatzer Steerable Delivery Sheath | ABBOTT MEDICAL | Mar 9, 2022 | SESE |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | Vascular Solutions, LLC | Feb 9, 2022 | SESE |
| K214106 | QuikPass Catheter | Traverse Vascular, Inc. | Jan 28, 2022 | SESE |
| K210009 | Guiding Catheter | CenterPoint Systems, LLC | Nov 24, 2021 | SESE |
| K210322 | XO Cross Support Catheter | Transit Scientific, LLC | Oct 21, 2021 | SESE |
| K212738 | Amplatzer Talisman Delivery Sheath | ABBOTT MEDICAL | Sep 27, 2021 | SESE |
| K212026 | Amplatzer Steerable Delivery Sheath | ABBOTT MEDICAL | Sep 27, 2021 | SESE |
| K212725 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | Sep 24, 2021 | SESE |
| K211240 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | Aug 26, 2021 | SESE |
| K212228 | WATCHMAN FXD Curve Access System | Boston Scientific Corporation | Aug 13, 2021 | SESE |
| K211990 | Rist 071 Radial Access Guide Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Jul 27, 2021 | SESE |
| K210431 | ReCross | Imds Operations B.V. | Jul 15, 2021 | SESE |
| K201726 | Arterial Catheter | Haolang Medical USA Corporation | Jul 7, 2021 | SESE |
| K210188 | coraCross | Reflow Medical | May 28, 2021 | SESE |
| K211251 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | May 26, 2021 | SESE |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | Vascular Solutions, LLC | Apr 30, 2021 | SESE |
| K210601 | Plato 17 Microcatheter | Scientia Vascular, LLC | Apr 28, 2021 | SESE |
| K210110 | Guidion | Imds Operations B.V. | Mar 31, 2021 | SESE |
| K203521 | FineCross M3 | Ashitaka Factory of Terumo Corporation | Mar 3, 2021 | SESE |
| K203275 | Recon Support Catheter | C.R. Bard, Inc. | Mar 1, 2021 | SESE |
| K210230 | Phenom Catheters | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | Feb 25, 2021 | SESE |
| K202610 | Ventrax Delivery System | Merit Medical Systems, Inc. | Dec 14, 2020 | SESE |
| K201811 | coraForce and coraFlex Support Catheters | Reflow Medical, Inc. | Oct 26, 2020 | SESE |
| K193474 | Selectra 3D Outer Guiding Catheters | Biotronik, Inc. | Oct 16, 2020 | SESE |
| K202252 | ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), | Asahi Intecc Co., Ltd. | Sep 8, 2020 | SESE |
| K200324 | NHancer Rx | Imds Operations B.V. | Aug 6, 2020 | SESE |
| K192712 | Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter | Medtronic, Inc. | Aug 3, 2020 | SESE |
| K193607 | BOBBY Balloon Guide Catheter | MicroVention, Inc. | Jul 21, 2020 | SESE |
| K193119 | Twin-Pass Dual Access Catheter | Vascular Solutions, LLC | Jun 29, 2020 | SESE |
| K201271 | Benchmark BMX96 Access System | Penumbra, Inc. | Jun 11, 2020 | SESE |
| K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | Jun 3, 2020 | SESE |
| K200317 | Support Catheter | Qxmedical, LLC | May 14, 2020 | SESE |
| K193420 | XO Cross Support Catheter | Transit Scientific | May 6, 2020 | SESE |
| K192558 | Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter | Mivi Neurovascular | Apr 6, 2020 | SESE |
| K193322 | NovaCross CTO Microcatheter | Nitiloop , Ltd. | Apr 2, 2020 | SESE |
| K200094 | speX LP Support Catheter | Reflow Medical | Mar 18, 2020 | SESE |
| K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | Feb 20, 2020 | SESE |
| K193012 | speX Support Catheter | Reflow Medical | Feb 19, 2020 | SESE |
| K191229 | TrapIt | Imds Operations B.V. | Jan 21, 2020 | SESE |
| K191717 | Route 92 Medical Sheath System | Route 92 Medical, Inc. | Jan 13, 2020 | SESE |
| K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | Biocardia | Jan 7, 2020 | SESE |
| K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) | MicroVention, Inc. | Dec 24, 2019 | SESE |
| K191551 | RIST Cath Radial Access Long Sheath | Rist Neurovascular, Inc. | Dec 23, 2019 | SESE |
| K190833 | AXS Vecta Aspiration Catheter | Stryker Neurovascular | Dec 15, 2019 | SESE |
| K191163 | Lumax Guiding Catheter | Cook Incorporated | Dec 12, 2019 | SESE |
| K193034 | AXS Infinity LS Plus Long Sheath | Stryker Neurovascular | Nov 29, 2019 | SESE |
| K192782 | ASAHI CROSSWALK Peripheral Support Catheter | Asahi Intecc Co., Ltd. | Nov 29, 2019 | SESE |
| K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | Nov 21, 2019 | SESE |
| K192625 | PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company | Nov 21, 2019 | SESE |
| K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | Nov 8, 2019 | SESE |
| K192525 | 087 Balloon Guide Catheter System | Q'Apel Medical, LLC | Oct 31, 2019 | SESE |
| K192296 | Medtronic 6F Taiga Guiding Catheter | Medtronic Vascular | Sep 20, 2019 | SESE |
| K191664 | SelectFlex 072 Neurovascular Access System | Q'Apel Medical | Aug 30, 2019 | SESE |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | Vascular Solutions, LLC | Aug 9, 2019 | SESE |
| K183305 | Crossing Support Catheter | Tractus Vascular, LLC | Aug 5, 2019 | SESE |
| K182487 | CerusEndo Microcatheter | Cerus Endovascular, Inc. | Jul 20, 2019 | SESE |
| K190749 | 087 Balloon Guide Catheter System | Q'Apel | Jul 15, 2019 | SESE |
| K182829 | Scepter Mini Occlusion Balloon Catheter | MicroVention, Inc. | Jul 10, 2019 | SESE |
| K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | Centerpoint Systems | Jun 28, 2019 | SESE |
| K182844 | ASAHI SASUKE | Asahi Intecc Co., Ltd. | Jun 22, 2019 | SESE |
| K182937 | Upstream GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | May 23, 2019 | SESE |
| K182602 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | May 15, 2019 | SESE |
| K190393 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | May 9, 2019 | SESE |
| K190581 | Amplatzer Trevisio Intravascular Delivery System | ABBOTT MEDICAL | Apr 5, 2019 | SESE |
| K183353 | Telescope Guide Extension Catheter | Medtronic, Inc. | Mar 22, 2019 | SESE |
| K190431 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | Mar 21, 2019 | SESE |
| K182918 | Ballast 088 Long Sheath | Balt USA, LLC | Mar 21, 2019 | SESE |
| K190401 | MAMBA and MAMBA Flex Microcatheters | Boston Scientific Corporation | Mar 15, 2019 | SESE |
| K183493 | SelectSite C304-HIS Deflectable Catheter System | Medtronic, Inc. | Mar 15, 2019 | SESE |
| K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm | Stryker | Mar 13, 2019 | SESE |
| K182570 | Venture 0.014 Catheter | Vascular Solutions, LLC | Mar 13, 2019 | SESE |
| K183000 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | Dec 29, 2018 | SESE |
| K182420 | ASAHI Corsair Pro XS | Asahi Intecc Co., Ltd. | Dec 20, 2018 | SESE |
| K180797 | Xcess Guiding Catheter | Curatia Medical Co. | Dec 14, 2018 | SESE |
| K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | Dec 13, 2018 | SESE |
| K182512 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | Dec 10, 2018 | SESE |
| K180889 | Tractus Crossing Support Catheter | Tractus Vascular, LLC | Dec 7, 2018 | SESE |
| K182097 | React 71 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Nov 14, 2018 | SESE |
| K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | Nov 9, 2018 | SESE |
| K180919 | GORE Tri-Lumen Catheter | W. L. Gore and Associates, Inc. | Oct 5, 2018 | SESE |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | Access Scientific, LLC | Sep 26, 2018 | SESE |
| K181000 | SelectFlex 072 Neurovascular Access System | Q'Apel | Sep 13, 2018 | SESE |
| K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length | Imperative Care, Inc. | Aug 8, 2018 | SESE |
| K180864 | WATCHMAN TruSeal Access System | Boston Scientific | Jul 20, 2018 | SESE |
| K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Jul 4, 2018 | SESE |
| K180959 | Phenom 27 Catheter | Cathera, Inc. | Jun 11, 2018 | SESE |
| K180201 | Route 92 Medical Access System | Route 92 Medical, Inc. | May 23, 2018 | SESE |
| K180986 | XableCath Support Catheter Product Family | Xablecath, Inc. | May 15, 2018 | SESE |
| K173661 | Wingman 35 Crossing Catheter | Reflow Medical, Inc. | Apr 18, 2018 | SESE |
| K172014 | Wedge Microcatheter | MicroVention, Inc. | Apr 5, 2018 | SESE |
| K180088 | TrapLiner catheter | Vascular Solutions, Inc. | Apr 4, 2018 | SESE |
| K173548 | Merit Pursue Microcatheter | Merit Medical Systems, Inc. | Mar 30, 2018 | SESE |
| K173799 | NaviCross 0.018 | Terumo Corporation | Mar 29, 2018 | SESE |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | Inneuroco, Inc. | Jan 26, 2018 | SESE |
| K173560 | Microcatheter | Surmodics,Inc. | Jan 12, 2018 | SESE |
| K171819 | Attain Assist CS Access Catheter | Creganna Medical Also Doing Business AS Ceganna Tactx Medica | Jan 4, 2018 | SESE |
| K173662 | speX Support Catheter | Reflow Medical, Inc. | Dec 20, 2017 | SESE |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | Inneuroco, Inc. | Dec 6, 2017 | SESE |
| K170914 | TXM Support Catheter | Texasmedical Technologies, Inc. | Nov 21, 2017 | SESE |
| K170664 | Odyssey Micro Catheter | Heraeus Medical Components, LLC | Nov 9, 2017 | SESE |
| K172090 | GuideLiner V3 Catheter | Vascular Solutions, Inc. | Oct 20, 2017 | SESE |
| K171672 | 065 Zenith, 074 Zenith | Inneuroco, Inc. | Oct 19, 2017 | SESE |
| K172297 | NovaCross Microcatheter | Nitiloop , Ltd. | Oct 18, 2017 | SESE |
| K171176 | M-CATH Microcatheter | Acrostak (Schweiz) AG | Sep 15, 2017 | SESE |
| K170041 | XableCath Support Catheter | Xablecath, Inc. | Sep 7, 2017 | SESE |
| K171452 | MAMBA and MAMBA FLEX Microcatheters | Boston Scientific Corporation | Aug 21, 2017 | SESE |
| K163259 | AXS Offset Delivery Assist Catheter | Stryker Neurovascular | Jul 28, 2017 | SESE |
| K171913 | Rubicon 14, 18 and 35 Support Catheters | Boston Scientific Corporation | Jul 25, 2017 | SESE |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Codman & Shurtleff, Inc. | Jul 3, 2017 | SESE |
| K171612 | ACUITY Pro Lead Delivery System | Boston Scientific Corporation | Jun 30, 2017 | SESE |
| K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | Jun 23, 2017 | SESE |
| K170996 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | Jun 9, 2017 | SESE |
| K171335 | Venture 038 catheter | Vascular Solutions, Inc. | Jun 7, 2017 | SESE |
| K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | May 31, 2017 | SESE |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter | Mivi Neuroscience, Inc. | Apr 6, 2017 | SESE |
| K163314 | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter | Boston Scientific Corporation | Mar 23, 2017 | SESE |
| K170403 | CenterCross Ultra LV Catheter | Roxwood Medical, Inc. | Mar 7, 2017 | SESE |
| K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | Feb 18, 2017 | SESE |
| K161901 | TrapLiner catheter | Vascular Solutions, Inc. | Feb 3, 2017 | SESE |
| K162467 | Twin-Pass Torque | Vascular Solutions, Inc. | Feb 1, 2017 | SESE |
| K162253 | Trapper Exchange Device | Creganna Medical Aslo Business AS Cregganna Tactx Medical | Jan 6, 2017 | SESE |
| K162563 | YOGA Microcatheter | Codman & Shurtleff, Inc. | Jan 5, 2017 | SESE |
| K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | Dec 23, 2016 | SESE |
| K160561 | Boosting Catheter | Qxmedical, LLC | Nov 2, 2016 | SESE |
| K161546 | R2P SlenGuide | Ashitaka Factory of Terumo Corporation | Oct 14, 2016 | SESE |
| K161152 | Navien Intracranial Support Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Oct 12, 2016 | SESE |
| K162384 | TrailBlazer Angled Support Catheter | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | Sep 22, 2016 | SESE |
| K162359 | Surefire Guiding Catheter | Surefire Medical, Inc. | Sep 21, 2016 | SESE |
Top Applicants
- Medtronic Vascular — 31 clearances
- Biotronik, Inc. — 23 clearances
- Vascular Solutions, Inc. — 21 clearances
- Cordis Corp. — 21 clearances
- Cook, Inc. — 20 clearances
