FDA Product Code
FDA Product Code DQY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 896 records · page 1 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | 2026-09-18 | Special | PDF ↗ |
| K260559 | NHanceIT | IMDS Operation B.V. | 2026-08-14 | Traditional | PDF ↗ |
| K262392 | APRO 35 Swift Catheter | Alembic, LLC | 2026-08-12 | Special | PDF ↗ |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 | Special | PDF ↗ |
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 | Special | PDF ↗ |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026-07-02 | Special | PDF ↗ |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026-06-17 | Special | PDF ↗ |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026-06-05 | Traditional | PDF ↗ |
| K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026-04-24 | Special | PDF ↗ |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 | Traditional | PDF ↗ |
| 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 | 2026-03-13 | Special | PDF ↗ |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 | Traditional | PDF ↗ |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 | Traditional | PDF ↗ |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 | Traditional | PDF ↗ |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 | Special | PDF ↗ |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 | Traditional | PDF ↗ |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 | Special | PDF ↗ |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025-06-25 | Traditional | PDF ↗ |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025-06-18 | Special | PDF ↗ |
| K250219 | Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2025-06-17 | Traditional | PDF ↗ |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025-06-02 | Traditional | PDF ↗ |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 2025-05-02 | Traditional | PDF ↗ |
| K251014 | APRO 45 Catheter | Alembic, LLC | 2025-05-01 | Special | PDF ↗ |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | 2025-04-29 | Special | PDF ↗ |
| K250426 | Amulet Steerable Delivery Sheath | ABBOTT MEDICAL | 2025-04-25 | Special | PDF ↗ |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | 2025-04-17 | Traditional | PDF ↗ |
| K243691 | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | 2025-04-04 | Special | PDF ↗ |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. | 2025-03-27 | Special | PDF ↗ |
| K243436 | Seclusion Catheter | Basis Medical | 2025-02-28 | Traditional | PDF ↗ |
| K242873 | Ventrax Delivery System | Merit Medical Systems, Inc. | 2025-01-15 | Special | PDF ↗ |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 | Traditional | PDF ↗ |
| K243224 | MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) | ABBOTT MEDICAL | 2024-12-31 | Traditional | PDF ↗ |
| K242644 | SENDERO MAX Delivery Catheter | Okami Medical, Inc. | 2024-12-20 | Traditional | PDF ↗ |
| K240885 | Shadow Catheter | Simpson Interventions, Inc. | 2024-12-19 | Traditional | PDF ↗ |
| K243180 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2024-12-04 | Special | PDF ↗ |
| K242276 | CrossFAST Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. | 2024-09-30 | Traditional | PDF ↗ |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | Biotronik, Inc. | 2024-09-12 | Traditional | PDF ↗ |
| K241611 | ShapeIT (SI014135) | Imds Operations B.V. | 2024-09-03 | Traditional | PDF ↗ |
| K241538 | TriClip Steerable Guide Catheter | ABBOTT MEDICAL | 2024-08-26 | Traditional | PDF ↗ |
| K233637 | Cordis BRITECROSS Support Catheter | Cordis US Corp | 2024-06-28 | Traditional | PDF ↗ |
| K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 | Asahi Intecc Co., Ltd. | 2024-06-25 | Traditional | PDF ↗ |
| K241177 | React 71 Catheter | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2024-05-28 | Special | PDF ↗ |
| K234115 | APRO 55 Catheter | Alembic, LLC | 2024-03-15 | Traditional | PDF ↗ |
| K240384 | SENDERO Microcatheter | Okami Medical, Inc. | 2024-03-08 | Special | PDF ↗ |
| K233350 | SINC Support Catheter | Reflow Medical, Inc. | 2024-02-08 | Traditional | PDF ↗ |
| K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | 2024-02-01 | Special | PDF ↗ |
| K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-01-07 | Traditional | PDF ↗ |
| K233858 | TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences | 2023-12-27 | Traditional | PDF ↗ |
| K231600 | SENDERO Microcatheter | Okami Medical, Inc. | 2023-11-17 | Traditional | PDF ↗ |
| K231629 | 091 Balloon Guide Catheter | Eosolutions, Corp. | 2023-10-31 | Special | PDF ↗ |
| K232437 | Paragon 8F Balloon Guide Catheter | Wallaby Medical | 2023-10-13 | Traditional | PDF ↗ |
| K232690 | Amulet Steerable Delivery Sheath | ABBOTT MEDICAL | 2023-09-29 | Special | PDF ↗ |
| K232647 | Microcatheter | Surmodics,Inc. | 2023-09-29 | Special | PDF ↗ |
| K231246 | Ventrax Delivery System (VTR851) | Merit Medical Systems, Inc. | 2023-08-30 | Traditional | PDF ↗ |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | Medtronic Vascular | 2023-08-22 | Special | PDF ↗ |
| K223633 | Rubicon Control Support Catheter (H749394323506A1) | Boston Scientific Corporation | 2023-08-08 | Traditional | PDF ↗ |
| K231044 | R2P Navicross | Terumo Medical Corporation | 2023-07-27 | Traditional | PDF ↗ |
| K223728 | Micro Rx | Imds Operations B.V. | 2023-07-13 | Traditional | PDF ↗ |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | Medtronic Vascular | 2023-06-30 | Special | PDF ↗ |
| K231311 | CPS Direct Universal slittable outer guide catheter (DS2C029) | ABBOTT MEDICAL | 2023-06-02 | Special | PDF ↗ |
| K231176 | Stingray LP Catheter | Boston Scientific | 2023-05-25 | Special | PDF ↗ |
| K222023 | RayFlow | Hexacath | 2023-04-06 | Traditional | PDF ↗ |
| K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | 2023-03-09 | Special | PDF ↗ |
| K222603 | 6F Wallaby Long Sheath | Wallaby Medical, Inc. | 2023-03-02 | Traditional | PDF ↗ |
| K222115 | ISAAC Neurovascular Navigation Catheter | MicroVention, Inc. | 2023-01-10 | Traditional | PDF ↗ |
| K223178 | SelectSite C304 Deflectable Catheter System, C315 Delivery System | Medtronic | 2022-11-08 | Special | PDF ↗ |
| K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | Medtronic | 2022-11-07 | Traditional | PDF ↗ |
| K213466 | Houdini Cross Support Catheter | Cruzar Medsystems, Inc. | 2022-10-20 | Traditional | PDF ↗ |
| K221886 | Sublime Microcatheter | Surmodics,Inc. | 2022-10-14 | Traditional | PDF ↗ |
| K214024 | SOFIA 88 Catheter | MicroVention, Inc. | 2022-09-12 | Traditional | PDF ↗ |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | Vascular Solutions, LLC | 2022-08-18 | Special | PDF ↗ |
| K220331 | 091 Balloon Guide Catheter | Inneuroco, Inc. | 2022-07-29 | Traditional | PDF ↗ |
| K222037 | Selectra Lead Implantation System | Biotronik, Inc. | 2022-07-19 | Special | PDF ↗ |
| K221846 | Artix Ballon Guiding Sheath | Inari Medical | 2022-07-11 | Traditional | PDF ↗ |
| K221750 | CPS AIM Universal II Slittable Inner Catheter | ABBOTT MEDICAL | 2022-06-30 | Special | PDF ↗ |
| K220632 | Boss Crossing Support Catheter | Marvao Medical Devices, Ltd. | 2022-06-02 | Traditional | PDF ↗ |
| K220691 | LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension | Seigla Medical, Inc. | 2022-05-05 | Traditional | PDF ↗ |
| K220716 | Spartan SC 069 | Spartan Micro, Inc. | 2022-05-05 | Traditional | PDF ↗ |
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2022-05-04 | Special | PDF ↗ |
| K214107 | XO CROSS CORONARY Support Catheter | Transit Scientific, LLC | 2022-04-11 | Traditional | PDF ↗ |
| K220340 | Amplatzer Steerable Delivery Sheath | ABBOTT MEDICAL | 2022-03-09 | Special | PDF ↗ |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | Vascular Solutions, LLC | 2022-02-09 | Traditional | PDF ↗ |
| K214106 | QuikPass Catheter | Traverse Vascular, Inc. | 2022-01-28 | Traditional | PDF ↗ |
| K210009 | Guiding Catheter | CenterPoint Systems, LLC | 2021-11-24 | Traditional | PDF ↗ |
| K210322 | XO Cross Support Catheter | Transit Scientific, LLC | 2021-10-21 | Traditional | PDF ↗ |
| K212026 | Amplatzer Steerable Delivery Sheath | ABBOTT MEDICAL | 2021-09-27 | Traditional | PDF ↗ |
| K212738 | Amplatzer Talisman Delivery Sheath | ABBOTT MEDICAL | 2021-09-27 | Special | PDF ↗ |
| K212725 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | 2021-09-24 | Special | PDF ↗ |
| K211240 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | 2021-08-26 | Traditional | PDF ↗ |
| K212228 | WATCHMAN FXD Curve Access System | Boston Scientific Corporation | 2021-08-13 | Special | PDF ↗ |
| K211990 | Rist 071 Radial Access Guide Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-27 | Special | PDF ↗ |
| K210431 | ReCross | Imds Operations B.V. | 2021-07-15 | Traditional | PDF ↗ |
| K201726 | Arterial Catheter | Haolang Medical USA Corporation | 2021-07-07 | Traditional | PDF ↗ |
| K210188 | coraCross | Reflow Medical | 2021-05-28 | Special | PDF ↗ |
| K211251 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | 2021-05-26 | Special | PDF ↗ |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | Vascular Solutions, LLC | 2021-04-30 | Traditional | PDF ↗ |
| K210601 | Plato 17 Microcatheter | Scientia Vascular, LLC | 2021-04-28 | Traditional | PDF ↗ |
| K210110 | Guidion | Imds Operations B.V. | 2021-03-31 | Traditional | PDF ↗ |
| K203521 | FineCross M3 | Ashitaka Factory of Terumo Corporation | 2021-03-03 | Traditional | PDF ↗ |
Product code DQY · Class II · Cardiovascular. Data: openFDA.