FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Enroute 0.014'' Transcarotid Guidewire
K Number: K253746
·
Decision Mar 19, 2026
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
16
Review Days
114
Basic Information
- Device Name
- Enroute 0.014'' Transcarotid Guidewire
- K Number
- K253746
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lake Region Medical
- Date Received
- November 25, 2025
- Decision Date
- March 19, 2026
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Lake Region Medical
| K Number | Device Name | ||
|---|---|---|---|
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| K211741 | Pre-Formed Extra Support Guidewire | Nov 22, 2021 | Substantially Equivalent |
| K160643 | ENROUTE 0.014 Guidewire | Oct 18, 2016 | Substantially Equivalent |
| K151244 | Pre-Formed Guidewire | Jun 11, 2015 | Substantially Equivalent |
| K140536 | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE | Dec 17, 2014 | Substantially Equivalent |
| K142393 | PREDICATE III GUIDEWIRE | Nov 25, 2014 | Substantially Equivalent |
| K142397 | Predicate III Guidewire | Sep 19, 2014 | Substantially Equivalent |
| K140482 | MANDREL GUIDEWIRE | Apr 8, 2014 | Substantially Equivalent |
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