Zenith Micro Guidewire
Device Facts
| Record ID | K252317 |
|---|---|
| Device Name | Zenith Micro Guidewire |
| Applicant | Suzhou Zenith Vascular SciTech Limited |
| Product Code | MOF · Cardiovascular |
| Decision Date | Apr 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
Special Controls
*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
