DQX — Wire, Guide, Catheter Class II
FDA Device Classification
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 |
|---|
| 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 |
| K242824 | lake region medical | PTFE Guidewire | December 6, 2024 |
| K240818 | terumo corporation | R2P Radifocus Glidewire Advantage | November 26, 2024 |
| K240997 | abbott medical | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | November 6, 2024 |
| K241784 | teleflex medical | Arrow® Nitinol Wire | September 18, 2024 |
| K240859 | terumo corporation | Glidewire GT-R | August 21, 2024 |