Enroute 0.014'' Transcarotid Guidewire— 510(k) K253746
Substantially EquivalentLake Region Medical
FDA 510(k) clearance K253746 for Enroute 0.014'' Transcarotid Guidewire, Substantially Equivalent on 2026-03-19. Applicant: Lake Region Medical. Device class: 2.
Summary
Lake Region Medical's Enroute 0.014'' Transcarotid Guidewire is filed under DQX, catheter guide wires. The record lists only the 0.014'' size given in the name.
Class II, 21 CFR 870.1330. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
Lake Region Medical filed from Galway, Ireland. Review took 114 calendar days (November 25, 2025 to March 19, 2026).
Clearance details
- Applicant
- Lake Region Medical
- Product code
- Product code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
Recent devices under product code DQX
view allMore clearances from Lake Region Medical
view allAdverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.