PTL · Wire, Guide, Catheter, Exempt
Cardiovascular · 21 CFR 870.1330 · Class 2
Overview
| Product Code | PTL |
|---|---|
| Device Name | Wire, Guide, Catheter, Exempt |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
