DQX
- Product code
- DQX
- Device name
- Wire, Guide, Catheter
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1330
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 34
- Summaries archived here
- 32 (direct download)
- 510(k) clearances (all years, FDA)
- 766 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (34)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253667 | 2026-07-14 | Sp Medical A/S | Accoat Guide Wire | |
| K261640 | 2026-07-13 | Merit Medical Ireland , Ltd. | Merit MAK Nitinol/Gold-Tungsten Guide Wire | |
| K254137 | 2026-05-22 | Merit Medical Ireland, Ltd. | InQwire Amplatz Guide Wire | |
| K260544 | 2026-03-20 | FMD Co., Ltd. | FMD Peripheral Guide Wire F-14 Flex 6; FMD Periphera… | |
| K253746 | 2026-03-19 | Lake Region Medical | Enroute 0.014'' Transcarotid Guidewire | |
| K253262 | 2026-03-06 | Nano4imaging GmbH | EmeryGlide (EG18008901) | |
| K253847 | 2026-01-31 | Merit Medical Ireland, Ltd. | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | |
| K251385 | 2026-01-21 | Merit Medical Ireland, Ltd. | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwir… | |
| K252674 | 2026-01-09 | Solo Pace, Inc. | Solo Pace Fusion System (SOLOFUSE1) | |
| K251596 | 2025-11-09 | William Cook Europe Aps | Lunderquist Extra Stiff Wire Guide | |
| K250203 | 2025-10-17 | Sureax Medical, LLC | SureAx-Guide | |
| K250031 | 2025-10-03 | ABBOTT MEDICAL | Amplatzer Guidewire | |
| K251181 | 2025-08-29 | Merit Medical Ireland, Ltd. | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5);… | |
| K250552 | 2025-07-25 | ABBOTT MEDICAL | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Com… | |
| K250075 | 2025-06-13 | Medtronic, Inc. | Medtronic Stedi Extra Support Guidewire | |
| K243733 | 2025-04-02 | Asahi Intecc Co., Ltd. | SION blue PLUS | |
| K241962 | 2025-03-27 | Asahi Intecc Co., Ltd. | Crossloop | |
| K242597 | 2025-03-05 | Asahi Intecc Co., Ltd. | CROSSLEAD 0.018inch | |
| K241702 | 2025-02-06 | Asahi Intecc Co., Ltd. | CROSSLEAD 0.014inch | FDA |
| K241521 | 2024-12-10 | Merit Medical Systems, Inc. | Prelude Small O.D. Introducer Guide Wire | |
| K242824 | 2024-12-06 | Lake Region Medical | PTFE Guidewire | FDA |
| K240818 | 2024-11-26 | Terumo Corporation | R2P Radifocus Glidewire Advantage | |
| K240997 | 2024-11-06 | ABBOTT MEDICAL | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Com… | |
| K241784 | 2024-09-18 | Teleflex Medical | Arrow® Nitinol Wire | |
| K240859 | 2024-08-21 | Terumo Corporation | Glidewire GT-R | |
| K241510 | 2024-08-14 | Asahi Intecc Co., Ltd. | CROSSLEAD Tracker | |
| K240387 | 2024-06-21 | Asahi Intecc Co., Ltd. | MINAMO blue; MINAMO viola | |
| K240460 | 2024-06-13 | FMD Co., Ltd. | FMD Peripheral Guide Wire F-18 Flex 400 (CSU41540025… | |
| K240864 | 2024-05-24 | Opsens, Inc. | PacePro Wire | |
| K232662 | 2024-05-14 | Biomerics Nle | BNLE Hydrophilic Jacketed Peripheral Guidewire | |
| K230418 | 2023-10-28 | Merit Medical Systems, Inc. | Mighty Wire Guide Wire | |
| K232570 | 2023-10-24 | Medtronic Vascular | Steerant Super Stiff Guidewire | |
| K232578 | 2023-10-11 | Filmec Co. , Ltd. | VASSALLO GT 018 G12; VASSALLO GT 018 G30 | |
| K232574 | 2023-10-11 | Filmec Co. , Ltd. | VASSALLO GT Crossing14 |
Official FDA classification page: DQX
Classification and pathway per current FDA publications. Data from openFDA (CC0).