DQX — Wire, Guide, Catheter Class II
FDA product code DQX covers "Wire, Guide, Catheter", a Class II medical device regulated under 21 CFR 870.1330. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DQX
- Device Class
- Class II
- Regulation Number
- 870.1330
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253667 | sp medical | Accoat Guide Wire | July 14, 2026 |
| K261640 | merit medical ireland | Merit MAK Nitinol/Gold-Tungsten Guide Wire | July 13, 2026 |
| K254137 | merit medical ireland | InQwire Amplatz Guide Wire | May 22, 2026 |
| K260544 | fmd co | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 | March 20, 2026 |
| K253746 | lake region medical | Enroute 0.014'' Transcarotid Guidewire | March 19, 2026 |
| K253262 | nano4imaging | EmeryGlide (EG18008901) | March 6, 2026 |
| K253847 | merit medical ireland | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | January 31, 2026 |
| K251385 | merit medical ireland | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ | January 21, 2026 |
| K252674 | solo pace | Solo Pace Fusion System (SOLOFUSE1) | January 9, 2026 |
| K251596 | william cook europe aps | Lunderquist Extra Stiff Wire Guide | November 9, 2025 |
| K250203 | sureax medical | SureAx-Guide | October 17, 2025 |
| K250031 | abbott medical | Amplatzer Guidewire | October 3, 2025 |
| K251181 | merit medical ireland | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid | August 29, 2025 |
| K250552 | abbott medical | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | July 25, 2025 |
| K250075 | medtronic | Medtronic Stedi Extra Support Guidewire | June 13, 2025 |
| K243733 | asahi intecc co | SION blue PLUS | April 2, 2025 |
| K241962 | asahi intecc co | Crossloop | March 27, 2025 |
| K242597 | asahi intecc co | CROSSLEAD 0.018inch | March 5, 2025 |
| K241702 | asahi intecc co | CROSSLEAD 0.014inch | February 6, 2025 |
| K241521 | merit medical systems | Prelude Small O.D. Introducer Guide Wire | December 10, 2024 |