DQY
- Product code
- DQY
- Device name
- Catheter, Percutaneous
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1250
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 53
- Summaries archived here
- 48 (direct download)
- 510(k) clearances (all years, FDA)
- 895 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (53)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260559 | 2026-08-14 | IMDS Operation B.V. | NHanceIT | |
| K262392 | 2026-08-12 | Alembic, LLC | APRO 35 Swift Catheter | FDA |
| K261766 | 2026-07-29 | CenterPoint Systems, LLC | CPS Locator 3D Plus Delivery Catheter | |
| K262240 | 2026-07-29 | CenterPoint Systems, LLC | SSPC NXT Delivery Catheter | |
| K261825 | 2026-07-02 | Abbott | Amplatzer TorqVue LP Delivery System; Amplatzer Torq… | |
| K261631 | 2026-06-17 | Abbott Medical | Amplatzer TorqVue Exchange System | |
| K260289 | 2026-06-05 | Balosmark, Inc. | Perfect-O Ostial Positioning Catheter | |
| K260993 | 2026-04-24 | Abbott | Amplatzer TorqVue Delivery System | |
| K253361 | 2026-04-10 | OrbusNeich Medical (Shenzhen) Co., Ltd… | Teleport Glide Microcatheter | |
| K260499 | 2026-03-13 | ABBOTT MEDICAL | Amplatzer Trevisio Intravascular Delivery System; … | FDA |
| K253409 | 2025-12-19 | Medtronic, Inc. | C320LBB Delivery System (C320LBBS45), C320LBB Delive… | |
| K252417 | 2025-12-17 | ABBOTT MEDICAL | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | |
| K252390 | 2025-10-29 | Medtronic, Ireland | Telescope Guide Extension Catheter | |
| K250147 | 2025-08-22 | Centerpoint Systems | CPS Locator 3D Delivery Catheter | |
| K251277 | 2025-08-22 | Reflow Medical, Inc. | CoraForce Microcatheter, CoraFlex Microcatheter | |
| K250972 | 2025-06-29 | Pendracare | Primum Hydrophilic Guiding Catheter | |
| K250828 | 2025-06-27 | CenterPoint Systems, LLC | CPS Locator 3D Plus Delivery Catheter | |
| K243184 | 2025-06-25 | Strait Access Technologies Holdings | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | |
| K250492 | 2025-06-18 | CenterPoint Systems, LLC | FlexiGo 3D Delivery Catheter | FDA |
| K250219 | 2025-06-17 | Bard Peripheral Vascular, Inc. | Dorado PTA Balloon Dilatation Catheter | |
| K250410 | 2025-06-02 | W. L. Gore & Associates, Inc. | GORE® Tri-Lobe Balloon Catheter | |
| K243757 | 2025-05-02 | Shockwave Medical, Inc. | Shockwave CS Guide Catheter | |
| K251014 | 2025-05-01 | Alembic, LLC | APRO 45 Catheter | FDA |
| K250962 | 2025-04-29 | Alembic, LLC | APRO 55 Intermediate Catheter | |
| K250426 | 2025-04-25 | ABBOTT MEDICAL | Amulet Steerable Delivery Sheath | |
| K242337 | 2025-04-17 | Imds Operations B.V. | FlowGuide (FG60F); GuidionShort (GS60F) | |
| K243691 | 2025-04-04 | Seigla Medical, Inc. | LiquID .051 LP Guide Catheter Extension | |
| K250558 | 2025-03-27 | Medtronic, Inc. | SelectSite C304 Deflectable Catheter System (C304); … | |
| K243436 | 2025-02-28 | Basis Medical | Seclusion Catheter | |
| K242873 | 2025-01-15 | Merit Medical Systems, Inc. | Ventrax Delivery System | |
| K242588 | 2025-01-07 | OrbusNeich Medical (Shenzhen) Co., Ltd… | COREPASS Modular Microcatheter (FLEX); COREPASS Modu… | |
| K243224 | 2024-12-31 | ABBOTT MEDICAL | MitraClip G5 Steerable Guide Catheter (SGC0801); Tr… | |
| K242644 | 2024-12-20 | Okami Medical, Inc. | SENDERO MAX Delivery Catheter | |
| K240885 | 2024-12-19 | Simpson Interventions, Inc. | Shadow Catheter | |
| K243180 | 2024-12-04 | CenterPoint Systems, LLC | SSPC NXT Delivery Catheter | FDA |
| K242276 | 2024-09-30 | Vantis Vascular, Inc. | CrossFAST Integrated Microcatheter Guide Extension … | |
| K240787 | 2024-09-12 | Biotronik, Inc. | Selectra 3D Lead Delivery System (443624-443629, 451… | |
| K241611 | 2024-09-03 | Imds Operations B.V. | ShapeIT (SI014135) | |
| K241538 | 2024-08-26 | ABBOTT MEDICAL | TriClip Steerable Guide Catheter | |
| K233637 | 2024-06-28 | Cordis US Corp | Cordis BRITECROSS Support Catheter | |
| K241158 | 2024-06-25 | Asahi Intecc Co., Ltd. | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI… | |
| K241177 | 2024-05-28 | Micro Therapeutics Lnc. D/B/A Ev3 Neur… | React 71 Catheter | |
| K234115 | 2024-03-15 | Alembic, LLC | APRO 55 Catheter | |
| K240384 | 2024-03-08 | Okami Medical, Inc. | SENDERO Microcatheter | |
| K233350 | 2024-02-08 | Reflow Medical, Inc. | SINC Support Catheter | |
| K240018 | 2024-02-01 | Boston Scientific Corporation | WATCHMAN TruSteer Access System (M635TU90050) | |
| K231608 | 2024-01-07 | OrbusNeich Medical (Shenzhen) Co., Ltd… | Teleport XT Microcatheter | |
| K233858 | 2023-12-27 | Trisalus Life Sciences | TriSalus TriGuideTM Guiding Catheter | |
| K231600 | 2023-11-17 | Okami Medical, Inc. | SENDERO Microcatheter | |
| K231629 | 2023-10-31 | Eosolutions, Corp. | 091 Balloon Guide Catheter | |
| K232437 | 2023-10-13 | Wallaby Medical | Paragon 8F Balloon Guide Catheter | |
| K232647 | 2023-09-29 | Surmodics,Inc. | Microcatheter | |
| K232690 | 2023-09-29 | ABBOTT MEDICAL | Amulet Steerable Delivery Sheath |
Official FDA classification page: DQY
Classification and pathway per current FDA publications. Data from openFDA (CC0).